US 2012020 1902A1

(19) United States

(12) Patent Application Publication (10) Pub. No.: US 2012/0201902 A1
Modak et al. (43) Pub. Date: Aug. 9, 2012
(54) ANTMICROBAL/PRESERVATIVE Publication Classification
COMPOSITIONS COMPRISING
BOTANCALS (51) Int. Cl.
AOIN 59/6 (2006.01)
AOIP I/00 (2006.01)
(75) Inventors: Shanta M. Modak, River Edge, NJ AOIN3L/00 (2006.01)
(US); Nayana Baiju, Kochi (IN); AOIN 65/20 (2009.01)
Lauserpina A. Caraos, Hollis, NY AOIN 65/08 (2009.01)
(US); Hari Krishnan AOIN 65/00 (2009.01)
Ramachandran, New York, NY AOIN 65/42 (2009.01)
(US)
(52) U.S. Cl. ......... 424/618; 424/725; 424/729: 424/736;
(73) Assignee: The Trustees of Columbia 424/744; 424/745; 424/757; 424/776; 424/777;
University in the City of New 5147730
York, New York, NY (US)
(57) ABSTRACT
(21) Appl. No.: 13/335,363 The present invention relates to a preservative or antimicro
Filed:
bial compositions which comprise low concentrations of
(22) Dec. 22, 2011 botanical extracts, in Synergistic combinations with
Related U.S. Application Data alkanediols in a solvent system, optionally with fruit acids.
Additionally, the present invention relates to a preservative or
(63) Continuation of application No. antimicrobial compositions which comprise a silver com
04.0667, filed on Jun. 30, 2010. pound, an essential oil or individual constituent, one or more
Zinc salts, and one or more alkanediol. The compositions of
(60) Provisional application No. 61/22 1971, filed on Jun. the invention may be used in personal care products including
30, 2009, provisional application No. 61/221,991, wound care products or in veterinary use. Preferably, the
filed on Jun. 30, 2009, provisional application No. compositions of the invention have little or no human-detect
61/352,183, filed on Jun. 7, 2010. able fragrance.
US 2012/020 1902 A1 Aug. 9, 2012

ANTIMICROBAL/PRESERVATIVE ing direct virucidal effects against Herpes simplex viruses

COMPOSITIONS COMPRISING types 1 and 2 (Garcia et al., Phytother. Res. 17(9): 1073-1075;
BOTANCALS Minami, et al., 2003, Microbial Immunol. 47(a):681-684;
Schuhmacher et al., 2003, Phytomedicine 10:504-510).
CROSS-REFERENCE TO RELATED 0007 United States Patent Application Publication No.
APPLICATIONS 20050048139 by Modaket al., published Mar. 3, 2005, relates
0001. The present application claims priority to U.S. to topical compositions comprising an emollient solvent and
Application Ser. Nos. 61/221,971, filed Jun. 30, 2009: an essential oil, which may further comprise additional addi
61/221,991, filed Jun. 30, 2009; and 61/352,183, filed Jun. 7, tives, among which citric acid, glycolic acid and lactic acid
are cited.
2010, the disclosure of which are incorporated herein by 0008 United States Patent Application Publication No.
reference in their entireties.
200500 19431 by Modak et al., published Jan. 27, 2005,
1. INTRODUCTION relates to compositions comprising a quaternary ammonium
compound and an essential oil (or active component thereof).
0002 The compositions of the present invention contain 0009. A number of patent applications relate to composi
combinations of low concentrations of essential oils and tions comprising an essential oil (or component thereof)
botanical extracts (including plant extracts and fruit extracts), where zinc salts are added to inhibit irritation associated with
in Synergistic combinations with alkanediols and solvents. essential oils. Examples of Such patent applications include
The compositions optionally contain a fruit acid or anti-in United States Patent Application Publication No.
flammatory agent as well. In specific embodiments, certain 2004.0102429 by Modak et al., published May 27, 2004 and
concentrations of the solvent benzyl alcohol have been found United States Patent Application Publication No.
to exhibit synergistic antimicrobial efficacy with certain 20050238602 by Modaket al., published Oct. 27, 2005, now
botanical acids, especially fruit acids. U.S. Pat. No. 7,435,429.
0003. The present invention additionally relates to com (0010 U.S. Pat. No. 6,858.317 by Aamodt et al., issued
positions containing silver Sulfadiazine, an antimicrobial Feb. 22, 2005, relates to methods for protecting wood from
agent and calendula oil, a wound healing agent. The compo mold and sap staining fungi which employ a non-toxic mold
sitions optionally contain silver releasing agents and/or anti inhibitor which may be a plant extract such as an essential oil.
fungal activity enhancers. The compositions may be used in (0011 U.S. Pat. No. 5,100,652 by Kross et al., issued Mar.
topical hydrophilic creams for the treatment of burns, 31, 1992, relates to low concentration chlorous-acid generat
wounds, and Surface infections. ing oral hygiene compositions which may comprise an essen
0004 Preferably, the inventive compositions have very tial oil as a flavoring agent.
mild or little to no fragrance. The compositions of the inven (0012 U.S. Pat. No. 5,310,546 by Douglas, issued May 10,
tion may be used as non-toxic, non-fragrant alternatives to 1994, relates to a mouth rinse preparation comprising hydro
conventional preservatives or may be combined with other gen peroxide, Zinc chloride, sodium citrate, Sodium lauryl
antimicrobial agents to enhance their activity, and may be Sulfate, citric acid and ethanol and optionally an essential oil
particularly useful in personal care and Veterinary product which is a denaturing agent.
applications. 0013 BiON offers several skin care products comprising
2. BACKGROUND OF THE INVENTION citric acid, botanicals, and other agents for topical use (San
Diego, Calif., US).
0005 Essential oils are volatile oils obtained from plant or (0014) Johnson et al. (U.S. Pat. No. 6,319,958 and
animal sources and are composed of complex mixtures of US20020165130) relates to the use of sesquiterpenoids to
several constituents, such as monoterpenes and sesquiterpene promote uptake of exogenous antimicrobial compounds.
hydrocarbons, monoterpene and sesquiterpene alcohols, Similarly, a related article discloses the use of sesquiterpe
esters, ethers, aldehydes, ketones, oxides and the like. These noids. Such as nerolidol, farnesol, bisabolol and apritone, in
essential oils and their isolated constituents are frequently enhancing bacterial permeability and Susceptibility to exog
utilized as fragrance and flavor agents, and have been widely enous antimicrobial compounds, suggesting that sesquiterpe
used in folk medicine for wound healing properties. noids have a non-specific and general effect (Brehm-Stecher
0006 Scientific research has corroborated the beneficial et al. 2003, Antimicrobial Agents and Chemotherapy, 47(10):
effects of essential oils. Essential oils of eucalyptus have been 3357-3360). In particular, Brehm-Stecher et al. report that
found to “possess central and peripheral analgesic effects as nerolidol, farnesol, bisabolol and apritone enhanced the Sus
well as neutrophil-dependent and independent anti-inflam ceptibility of S. aureus to the antibiotics erythromycin, gen
matory activities” (Silva et al., 2003, J. Ethnopharmacol. tamicin, Vancomycin, ciproflaxin, clindamycin, and tetracy
89(2-3); 277-283), and similar activity has been observed in cline.
essential oils from Lavendula angustifolia Mill. (Hahashemi (0015 U.S. Pat. No. 4,867,898 by Spaulding et al., issued
et al., 2003, J. Ethnopharmacol. 89(1):67-71). Essential oils Sep. 19, 1989, relates to a liquid hard surface cleaner com
have been demonstrated to exhibit antibacterial (Bezic et al., prising pine oil and organic, oil-soluble acids at a pH from
2003, Phytother. Res. 17(9:1037-1040: Goren et al., 2003, Z. 0-6.
Naturforsch. 58(9-10):687-690; de Abreu Gonzaga et al., (0016 U.S. Pat. No. 6,753,305 by Raso and Caselli, issued
2003, Planta Med. 69(8:773-775; Valero and Salmera, 2003, Jun. 22, 2004, relates to a hard surface disinfectant compris
Int. J. Food Microbiol. 85(1-2): 73-81) and antifungal ing up to 20 percent of cinnamon oil or a component thereof,
(Paranagama et al., 2003, Lett. Appl. Microbiol. 37(1):86-90; 0.01-5 percent of an organic acid, and optionally an additional
Shin, 2003, Arch. Pharm. Res. 26(5):389-393: Velluti et al., essential oil.
2003, Int. J. Food Microbiol. 89:145-154) activities. Viru 0017 International Patent Application Publication No.
cidal activity of essential oils has also been observed, includ WO2007/077573 by Mukhopadhyay, published Jul. 12,
US 2012/020 1902 A1 Aug. 9, 2012

2007, relates to antimicrobial compositions comprising an component (i.e., an “Individual Constituent” or “IC)
antimicrobial agent, Such as triclosan, and a functionalized thereof) and one or more botanical extract, Such as a plant or
hydrocarbon, where the functionalized hydrocarbon can be fruit extract, in combination with one or more alkanediol and
an essential oil, and/or a solvent. one or more solvent. The invention is based, at least in part, on
0018 Infection continues to be the major problem in the the discovery that certain low concentrations of specific com
management of patients with burn wounds, decubitus ulcers binations of these ingredients have an unexpected Synergistic
and other surface infections. Control of skin infections is effect, namely the combinations can confer Superior antimi
most important in preventing bacteremia and enhancing crobial properties on personal care, veterinary, as well as
wound healing. Topical creams containing silver Sulfadiazine household products. Preferably, all components of the preser
and other topical antimicrobial agents have been developed Vative composition are derived from a natural (rather than a
and widely used for Such purposes. However, complete con synthetic) source. Preferably, the compositions of the inven
trol of target infection has not been achieved with the use of tion have little or no human-discernable fragrance.
these agents. 0026. In various non-limiting embodiments, the composi
0019 1% silver sulfadiazine (SilvadeneR) cream has been tions of the present invention may include one or more botani
effectively used as a prophylactic cream to control burn cal extract, benzyl alcohol, and 1,3-propanediol, wherein the
wound infections. However, it is not very effective in treating amounts of botanicals and benzyl alcohol are presentina ratio
established deep wound infections due to the drug's failure to of about 1:1 to 1:12, and wherein the composition pH ranges
penetrate the wound eschar. The incidence of wound coloni from 3-5. Optionally, the compositions may further contain
zation with S. aureus or C. albicans in SilvadeneR) treated fruit acids, additional solvents and/or anti-inflammatory
patients has spurred research for other agents. compounds.
0020. It has been well established that continuous control 0027. In various non-limiting embodiments, the present
of infection facilitates rapid healing of partial thickness invention may be utilized in personal care products such as
burns, decubitus ulcers and other types of Surgical wounds Soaps, scrubs, cosmetics, topical creams and lotions, wound
and facilitates their closure. Wound healing, especially in care products, burn wound cream, decubitous ulcer cream
burns, is a complex process for which Zinc has been found (with anti-inflammatory botanicals and the use of silver sul
essential. Studies on Zinc have shown beneficial results in fadiaZene as an anti-microbial agent), rapidly acting skin
wound healing with acceleration of the re-epithelialization disinfectants, disinfecting wipes, and Veterinary products,
process and an antibacterial effect. Zinc oxide has been Such as antimicrobial lotion for mastitis, teat dip, and thera
reported to activate endogenous zinc-dependent matrix met peutic ointments. The compositions of the invention may be
alloproteinases, augment expression of endogenous growth used in concentrations from about 1% to about 10% in per
factors and facilitate keratinocyte migration. Sonal care products or topical creams.
0021. In earlier studies, topical treatment of burn wounds 0028. The present invention relates to topical creams con
with Zinc sulfadiazine was found to accelerate wound healing taining antimicrobial agents such as silver salts, calendula
better than treatment with silver sulfadiazine. (Gyn and oil, Zinc salts, and curcumin compounds. Non-limiting
Obstet, 142:553-559 (1976)). examples of silver salts include silver sulfadiazine, silver
0022. To prevent or reduce infection ofburn wounds, topi nitrate, silver carbonate, and silver oxide. Additional antimi
cal ointments have been used. These ointments have incorpo crobial agents include biguanides (chlorhexidine or polyhex
rated silver sulfadiazine (U.S. Pat. No. 3,761,590, incorpo amethelene biguanide), phenoxyethanol, miconazole, poly
rated herein by reference) or various antibiotics. A topical mixin, neomycin bacitracin and povidone iodine. These
ointment for burns has also been reported which contains a antimicrobial agents provide for the control of infection and
combination of silver salts and norfloxocin, a quinoline anti promote wound healing in a wide variety of skin lesions,
biotic, or its salts (U.S. Pat. No. 4,404,197, incorporated including burns, abrasions, decubitus ulcers, and other local
hereby by reference). In the case where the antibiotic is silver infections.
norfloxocin, U.S. Pat. No. 4,404,197 reports a synergistic 0029. Furthermore, the synergistic combination of benzyl
enhancement of activity. U.S. Pat. No. 5,374,432 relates to alcohol and 1.3 propanediol, octanediol and decanediol.
topical anti-infective ointments containing an antibiotic, sil which exhibit antifungal activity, is used in the above
versalt, and sterile carrier. These compositions were found to described topical cream to enhance the antifungal activity.
not only provide improved antimicrobial efficacy, but also Lactic acid or citric acid is used to assist in the controlled
reduced incidence of microbial resistance. release of silver.
0023 U.S. Pat. No. 6,987,133 relates to a topical prepara
tion containing silver Sulfadiazine dispersed or solubilized in 4. DETAILED DESCRIPTION OF THE
a cream or lotion base matrix which can be sprayed directly INVENTION
on the burn wound. European Patent No. EP0653214 relates 0030. For clarity of description, and not by way of limita
to a topical antibacterial preparation containing silver Sulfa tion, the detailed description of the invention is divided into
diazine and collagen for the treatment of infected hands and the following subsections:
for the advancement of their healing. 0031 (4.1) essential oils;
0024. There is a continuing desire for an antimicrobial or 0032 (4.2) botanical extracts;
wound healing composition that are non-irritating, safe, and 0033 (4.3) alkanediols;
effective for repeated use in various professional and non 0034 (4.4) solvents:
professional settings.
0035 (4.5) fruit acids:
3. SUMMARY OF THE INVENTION 0036 (4.6) combinations of solvents, botanical extracts,
and alkanediols;
0025. The compositions of the invention contain low con 0037 (4.7) silver and silver salts:
centrations of one or more essential oil (and/or one or more 0038 (4.8) zinc and zinc salts;
US 2012/020 1902 A1 Aug. 9, 2012

0039 (4.9) antimicrobials; present invention. In specific non-limiting embodiments of

0040 (4.10) synergistic combinations of benzyl alcohol the invention, an IC is selected from the (non-limiting) group
and alkanediols; consisting of camphor, curcumin, alpha-pinene, constituents
0041 (4.11) personal care products: of cinnamon leaf oil Such as, cinnamaldehyde, cinnamylace
0042 (4.12) wound healing: tic ester, cinnamic acid, ethyl cinnamate, methyl chavicol,
0043 (4.13) veterinary products; linalool, beta-caryophyllene, and eugenol; constituents of
0044 (4.14) household/industrial products; and lemongrass oil Such as d-limonene, geranyl acetate, nerol,
0045 (4.15) medical devices. geraniol, citral, and/or myrcene; constituents of citronella oil
0046. In preferred, non-limiting embodiments, the com Such as geraniol, citronellol, citronellal, geranyl acetate,
positions of the invention have little or no human-discernable limonene, methylisoueugenol, and/or elemol; components of
fragrance or scent. While certain embodiments of the inven basil oil such as camphor, limonene, and/or B-selinene; and
tion may have a very slight scent, this scent is not sufficient to constituents of orange oil such as C-pinene, Sabinene,
Substantially distort or mask the scent of an added fragrance. myrcene, limonene, linalool, citronellal, neral and/or gera
Accordingly, the preservative compositions of the invention nial. An EO or IC for use in the invention may be obtained
may be used either in unscented products or, alternatively, in from its natural source or may be chemically synthesized.
products scented with a desired fragrance (for example, a 0052. In preferred non-limiting embodiments of the
fragrance associated with a particular brand of product). In invention, the EO is selected from one or more EO from the
the latter case, the preservative composition of the invention group consisting of cinnamon oil (CO) (bark or leaf), lemon
will not substantially alter (or preferably, detectably alter) the grass oil (LGO), and basil oil (BO), all of which have little to
character of the desired fragrance. Preferably, the composi no fragrance, or nonfragrant oils such as pomegranate seed oil
tions are fragrance-free. (PSO).
0047. In preferred, non-limiting embodiments of the 0053 Calendula contains high amounts of flavonoids,
invention, the compositions include botanicals, which plant-based antioxidants that protect the body against cell
include essential oils or individual constituents thereof, and damaging free radicals. It appears to have anti-inflammatory,
botanical extracts. Each category of botanicals is Summarized antiviral, and antibacterial effects. Animal studies show that
below. calendula accelerates wound healing, possibly by increasing
0048 “About as used in this document means plus or blood flow to the wounded area and by helping the body
minus 20 percent of the recited value, so that, for example, produce collagen proteins, which are used to heal skin and
“between about 0.125 and 1.0 percent’ means a range connective tissue.
between 0.125-0.025 and 1.0.0.2. 0054. In various non-limiting embodiments, low concen
trations of essential oils and ICs are used. Essential oils or ICs
4.1 Essential Oils
are present in Stock solutions in amounts ranging from about
0049 Essential oils (“EOs), as defined herein, are vola 0.05% to about 30% (w/w). In alternative embodiments, for
tile oils obtained from plant or animal sources, or their syn example compositions that may be used without dilution, the
thetic equivalents, and are composed of complex mixtures of amounts range from about 0.01% to about 1% (w/w). These
several constituents such as monoterpenes and sesquiterpene concentrations (and others recited throughout) may be
hydrocarbons, monoterpene and sesquiterpene alcohols, increased in stock solutions intended for dilution.
esters, ethers, aldehydes, ketones, oxides and the like. 0055. In specific non-limiting embodiments of the inven
Examples of EOs include, but are not limited to, cinnamon tion, an IC is selected from the (non-limiting) group consist
oil, basil oil, bergamot oil, clary sage oil, ylang-ylang oil, ing of a curcumin compound and calendula oil. In various
neroli oil, sandalwood oil, frankincense oil, ginger oil, pep non-limiting embodiments, low concentrations of essential
permint oil, lavender oil, jasmine absolute, geranium oilbour oils and ICs are used. Specifically, calendula oil are used in
bon, spearmint oil, clove oil, patchouli oil, rosemary oil, amounts ranging from about 0.3 to about 5% w/w, and cur
rosewood oil, Sandalwood oil, tea tree oil, Vanilla oil, lemon cumin compounds are used in amounts ranging from about
grass oil, cedarwood oil, balsam oils, tangerine oil, Hinoki 0.02 to about 0.2% w/w. These concentrations (and others
oil, Hiba oil, ginko oil, eucalyptus oil, lemon oil, orange oil, recited throughout) may be increased in stock solutions
Sweet orange oil, pomegranate seed oil, manuka oil, citronella intended for dilution.
oil, and calendula oil.
0050 Individual constituents (“ICs”) of essential oils may 4.2. Botanical Extracts
be isolated from the oil (natural) or may be entirely or par
tially chemically synthetic, and include, but are not limited to, 0056 Botanical extracts, as defined herein, include plant,
thyme, oregano, curcumin, 1-citronellol, C.-amylcinnamalde herbal, and fruit extracts, which are not “essential oils' as
hyde, lyral, geraniol, farnesol, hydroxycitronellal, isoeu noted above. The botanical extracts utilized herein include
genol, eugenol, camphor, eucalyptol, linalool, citral, thymol. but are not limited to Camelia sinensis (green tea), grapes,
limonene and menthol. Further examples of ICs include ses pomegranate, Echinacea, Centella Asiatica, Elderflower,
quiterpenoid compounds, which may be the active com Irish moss, Mallow, soap bark, Yucca, Clary Sage, oregano,
pounds in the essential oils. Sesquiterpenoid compounds, thyme, curcumin compounds, resveratrol (polyphenolic com
containing 15 carbons, are formed biosynthetically from pound from grape, berries, etc.) and mixtures thereof. The
three 5-carbon isoprene units. Sesquiterpenoid compounds botanical utilized to obtain the botanical extract may be
include, but are not limited to, farnesol, nerolidol, bisabolol, obtained from any of the plant parts including the leaves,
apritone, chamaZulene, Santalol, Zingiberol, carotol, and pulp, seeds, or stems, fruit and fruit seeds, as well as the whole
caryophyllen. plant. Herbal extracts can be, for example, standardized
0051 Mixtures of one or more EO one or more IC, and one extracts that are dispersible and/or soluble in aqueous
or more EOas well as one or more IC, are encompassed by the medium.
US 2012/020 1902 A1 Aug. 9, 2012

0057 Examples of herbal extracts include, without limi alkanediols. Suitable alkanediols include, but are not limited
tation, extracts of chamomile, rosemary, aloe, nettle, Centella to, propanediol, butanediol, dodecanediol, decanediol.
asiatica, ginkgo biloba, betula, and witch hazel. Such nonanediol, octanediol, heptanediol, hexanediol, and pen
extracts may be delivered in a carrier Such as water, propylene tanediol.
glycol, hydroalcohol, glycerine, or butylene glycol. Addi 0063. In particular non-limiting embodiments, the
tional extracts with nutritional quality can be used, including, alkanediols have a carbon backbone of between 3 and 25
without limitation, green tea, white tea, grape skin, grape carbon atoms, including but not limited to 1.9 Nonanediol,
seed, grapefruit, grapefruit seed, grapefruit peel, citrus fruits 1.2-Decanediol, 1,10-Decanediol, 1,11-Undecanediol, 1,2-
(other than grapefruit extract) bilberry, blueberry, Ginkgo Dodecanediol. 1, 12 Dodecanediol, Cyclododecanediol,
biloba, Soy isoflavones, soy extract, fermented soy protein, 1,13-Tridecanediol, 12-Tetradecanedio-1,1,14-Tetrade
black cohosh, St. John's wort, echinacea, chamomile, rose canediol, 1,15-Pentadecanediol, 1,16-Hexadecanediol, 1,17
mary, aloe extract and juice, nettle, coconut fruit and Centella Heptadecanediol. 1,18-Octadecanediol. 1,19-Nonade
asiatica. Botanical extracts can be obtained from, for canediol, 120-Eicosanediol, 1.21-Heneicosanediol, 1.22
example, Active Organics (Lewisville, Tex.), New Age Docosanediol, 1.23-Tricosanediol, 1,24-Tetracosanediol,
Botanicals (Garland, Tex.), Triarco Industries (Wayne, N.J.), 1.25-Pentacosanediol. A preferred non-limiting alkanediol is
and Aloecorp (Broomfield, Colo.). 1.3 propanediol (ZemeaR), which is a natural product pre
0058 Examples of nonfragrant botanicals include pome pared from corn Sugar.
granate seed oil (PSO), mixtures of edible plant extract 0064. In non-limiting embodiments of the invention, the
Kefiprotect (KP), and tetrahydrocurcuminoid (THC). Tur stock solution concentration of the alkanediols ranges from
meric and curcuminoids have been documented to have anti about 0.5% to about 70% (w/w), preferably from about 10%
inflammatory, antioxidant and wound healing properties. The to about 70% (w/w). In alternative embodiments, the concen
following curcuminoids can be used in topical creams, tet tration of alkanediols ranges from about 0% to about 50%
rahydrocurcumin, tetrahydrodemethoxycurcumin, tetrahy (w/w), preferably from about 0% to about 10% (w/w), more
drobisdemethoxycurcumin, and mixtures thereof. Additional preferably from about 5% to about 10% (w/w). In other
examples of botanical extracts include coconut derived phos embodiments, the concentration of alkanediols ranges from
pholipid (Arlasik phospholipid PTM), natural blends of fatty about 1% to about 5% (w/w).
acids which mimic those found in the stratum corneum, mix
ture of fatty acids with pigments such as carotenes, caro 4.4 Solvents
tenoids or phytosterols that are known to facilitate repair to 0065. In various non-limiting embodiments, the composi
damaged skin, and the like. Specific examples of useful
botanical extracts include avocado, which contains the Sterol tions of the present invention may include one or more sol
sitosterol; carrot, which contains beta carotene; sesame oil vent, including but not limited to solvent(s) selected from the
which contains a mixture of Saturated and unsaturated fatty group consisting of water, alcohols, glycols, glycerol, glyc
acids, and brazil nut oil. Because of its broad distribution of erine, octoxyglycerin, diglycerol, propylene glycol, dipropy
fatty acids, extracts such as brazil nut oil, can outperform lene glycol, and vegetable oils.
single fatty acids with respect to incorporation into the lipid 0.066 Preferred but non-limiting examples of non-al
lamellar structures. Brazil nut oil (BNO) originates from the kanediol alcohols for solubilisation are aliphatic alcohols
harvested fruit from the South American rain forest tree: having between about 1 and 8 carbonatoms such as methanol,
Bertholletia excelsa. ethanol, n-propanol, isopropyl alcohol, 2-methyl-2 propanol,
0059 Botanical extracts also include flavanoids and ter hexanol, or combinations thereof. Aromatic alcohols, for
penoids. The flavinoids contemplated by the present inven example, but not by way of limitation, phenoxyethanol, ben
tion include, but are not limited to, turin, quercetin, hesperi Zyl alcohol. 1-phenoxy-2-propanol, and/or phenethyl alco
din, and naringin. Terpenoids contemplated by the present hol, may also optionally be used in combination with ali
invention include, but are not limited to, monoterpenes, ses phatic alcohols.
quiterpenes, and diterpenes. 0067. Aromatic alcohols, for example, but not by way of
0060. In preferred non-limiting embodiments of the limitation, include phenoxyethanol, benzyl alcohol. 1-phe
invention, the botanical extract is selected from one or more noxy-2-propanol, and/or phenethyl alcohol, for example at a
extract selected from the group consisting of grapefruit seed concentration of between about 0.5 and 5% (weight/weight)
extract (GSE), pomegranate seed oil (PSO), citrus fruit may also optionally be used in combination with aliphatic
extract, or mixtures of edible plant extract Kefiprotect (KP). alcohols. A further solvent which optionally may be com
coconut derived phospholipid (Arlasik phospholipid PTM), prised in a composition of the invention is isopropyl
and tetrahydrocurcuminoid (THC). myristate. Additional aliphatic alcohols include ethanol,
0061. In various non-limiting embodiments, low concen denatured alcohol (SDA 40B and SDA 3C) and isopropanol.
trations of botanical extracts are used. Botanical extracts are 0068 Compositions comprising synergistic combination
present in Stock solutions in concentrations ranging from of benzyl alcohol, botanicals, and 1.3 propanediol and its
about 2.0% to about 45% (w/w), preferably from about 10% derivatives such as 2-methyl-1-nitro 1,3-propanediol (Diol)
to about 20% (w/w). In alternative embodiments, the concen or 2-Hydroxymethyl 2-nitro 1,3-propanediol (Triol), further
trations range from about 0% to about 20% (w/w), preferably contain cosolvents such as glycerin, octoxyglycerin, alcohol,
from about 0% to about 10% (w/w), preferably from about glycols, butanediol, and phenoxy ethanol.
0% to about 4% (w/w). Alternative embodiments use from 0069. In preferred non-limiting embodiments of the
about 5% to about 10% (w/w). invention, the solvent is benzyl alcohol, glycerin, or a com
bination thereof. The solvents are used in stock solution con
4.3 Alkanediols centrations ranging from about 0% to about 90% (w/w),
0062. In non-limiting embodiments, bifunctional alcohols preferably from about 0% to about 85% (w/w), preferably
which may be used according to the present invention are from about 0% to about 70% (w/w), preferably from about
US 2012/020 1902 A1 Aug. 9, 2012

30% to about 65% (w/w). Benzyl alcohol concentrations (w/w). In alternative embodiments, the concentrations range
range from about 0% to about 90%, more preferably from from about 0.2% to about 2% (w/w), more preferably from
about 0% to about 70%, preferably from about 5% to about about 0.2 to about 1% w/w.
90% (w/w). In other embodiments, the concentrations are
from about 1% to about 10% (w/w), more preferably from 4.6 Combinations of Solvents, Botanical Extracts,
about 5% to about 10% (w/w). In alternative embodiments, and Alkanediols
the concentration ranges range from about 5% to about 90% 0075. In various non-limiting embodiments, the present
(w/w), preferably from about 30% to about 90% (w/w), and invention provides for compositions comprising a combina
more preferably from about 40% to about 80% (w/w). In a tion of a solvent, a botanical extract, and an alkanediol. Pref
preferred embodiment, the solvent is a natural product, for erably, this combination produces a synergistic anti-micro
example, benzyl alcohol derived from the Cassia plant. bial effect against at least one microbe selected from the
0070. In alternative preferred non-limiting embodiments group consisting of Escherichia coli, Pseudomonas aerugi
of the invention, the solvent is benzyl alcohol or its deriva nosa, Staphylococcus aureus, methicillin-resistant S. aureus,
tives, e.g., hydroxylbenzyl alcohol, nitrobenzyl alcohol, or and Candida albicans (“synergistic’ means that the antimi
other derivatives. Benzyl alcohol concentrations ranging crobial effect of the combination is greater than the sum of the
from about 0.5% to about 10% (w/w), preferably from about antimicrobial effects of the individual components).
0.5% to about 5% (w/w), more preferably from about 0.5% to 0076. In particular, non-limiting embodiments, the
about 4% (w/w), have been found to exhibit synergistic anti present invention provides for formulations that are concen
microbial efficacy with certain botanical organic acids, and in trated and may be diluted to provide a composition for per
particular fruit acids. Alternative embodiments use from Sonal, household, or industrial use. The present invention
about 1.0% to about 5.0% (w/w), or from about 1% to about further provides for methods of providing an antimicrobial
3% (w/w) benzyl alcohol. Use of other botanicals and syn effect to a Surface comprising applying, to the Surface, an
thetic antimicrobials along with benzyl alcohol and these effective amount of a composition as described herein. An
acids further enhances the synergistic activity as discussed in antimicrobial effect means killing and/or inhibiting the
further detail below.
growth/proliferation of a microbe. In particular non-limiting
4.5 Fruit Acids embodiments of the invention, the microbe is selected from
the group consisting of from the group consisting of Escheri
0071 Fruit acids which may be used according to the chia coli, Pseudomonas aeruginosa, Staphylococcus aureus,
invention include but are not limited to citric acid, glycolic methicillin-resistant S. aureus, and Candida albicans. In spe
acid, lactic acid, malic acid, tartaric acid and acetic acid. In cific non-limiting embodiments, the composition is exposed
certain non-limiting embodiments, the fruit acid is Multifruit to the surface for at least 20 seconds, at least 30 seconds, or at
BSC (Arch Chemicals), which is a mixture of lactic, citric, least 60 seconds, or at least 5 minutes or at least 10 minutes.
tartaric, glycolic, and malic acid extracted from plants. In In various non-limiting embodiments, the Surface may be the
preferred non-limiting embodiments of the invention, the a skin or mucosal Surface, a household Surface (e.g., a Surface
fruit acid is lactic acid. A fruit acid for use in the invention of a countertop, table sink, toilet, wall, floor, appliance, win
may be obtained from its natural Source or may be chemically dow, shower Surface, rug, upholstery, fabric, etc.) or an indus
synthesized. trial Surface (e.g., a surface of a countertop, table sink, toilet,
0072 Organic acids may also be used according to the wall, floor, appliance, window, shower Surface, rug, uphol
invention. Organic acids includebut are not limited to benzoic stery, fabric, etc.).
acid and its derivatives including salt forms, for example, a 0077. In particular, non-limiting embodiments of the
benzyl benzoate, paramino benzoic acid, nitrobenzoic acid, invention, the compositions comprise between about 0.0 and
hydroxyl benzoic acid, fluorobenzoic acid, and benzyl sali 70% (w/w) of one or more solvent, between 10% and 70%
cylate. (w/w) alkanediols, and between about 2.0 and 45% (w/w)
0073 Fruit acids may be used according to the invention to essential oils and/or botanical extracts. In a particular
assist in the controlled release of the silver compound. Non embodiment of the invention, the compositions comprise
limiting examples of fruit acids include but are not limited to benzyl alcohol, 1.3 propanediol (ZemeaR), and grapefruit
citric acid, glycolic acid, lactic acid, malic acid, tartaric acid seed extract (GSE). Fragrance free botanicals such as grape
and acetic acid. In certain non-limiting embodiments, the fruit seed extract (GSE), Curcumin compounds (CRMN)
fruit acid is Multifruit BSC (Arch Chemicals), which is a with or without fruit acid exhibits synergistic antimicrobial
mixture of lactic, citric, tartaric, glycolic, and malic acid efficacy with benzyl alcohol. The stability and efficacy of the
extracted from plants. A fruit acid for use in the invention may composition can be enhanced by the use of 1.3 propanediol.
be obtained from its natural source or may be chemically 0078. The following table provides examples of such for
synthesized. In preferred non-limiting embodiments of the mulations.
invention, the fruit acid is lactic acid or citric acid.
0074. In non-limiting embodiments of the invention, the TABLE 1
stock Solution concentrations of the fruit acids ranges from % ww in
about 0% to about 70%, preferably from about 5% to about Preservative Ingredient stock
70%, more preferably from about 5% to about 20% (w/w),
more preferably from about 10% to about 20% (w/w). In Preservative 5 Benzyl alcohol
Zemea (R)
41.7
41.7
alternative non-limiting embodiments of the invention, the GSE 16.6
concentrations range from about 0% to about 40%, preferably Preservative 5A Benzyl alcohol (synthetic) 41.7
from about 0.1% to about 20% (w/w), more preferably from 1.3 propanediol (synthetic) 41.7
about 0.2% to about 4% (w/w), even more preferably from GSE 16.6
about 0.5% to about 4% (w/w), or from about 2% to about 4%
US 2012/020 1902 A1 Aug. 9, 2012

TABLE 1-continued TABLE 4

% ww in
% ww in Preservative Ingredient stock
Preservative Ingredient stock Preservative 13 GSE 16.7
Lactic acid 13.3
Zemea (R) 66.7
Preservative 15A GSE 16.7
Lemongrass oil 3.3
Zemea (R) 41.65 Preservative 14 GSE 16.7
Lactic acid 13.3
Benzyl alcohol 41.65 Benzyl alcohol 33.3
Lemongrass oil 3.3
Zemea (R) 33.3
0079. In preferred non-limiting examples of the invention,
lactic acidora comparable fruit acid is optionally added to the I0082 In certain non-limiting examples of the invention,
formulation.
the antimicrobial composition contains synergistic amounts
TABLE 2
of benzyl alcohol and botanicals. In these embodiments, the
inclusion of an alkanediol. Such as 1,3-propanediol, which
% ww in acts as an emollient solvent, is optional. The benzyl alcohol
Preservative Ingredient stock has been found to exhibit synergistic antimicrobial efficacy
Preservative 8 GSE 2O.O with certain botanical organic acids, in particular fruit acids.
Benzyl alcohol 33.3 Use of other botanicals and synthetic antimicrobials along
Glycerin 33.3 with benzyl alcohol and these acids further enhances the
Lactic acid 13.3
Preservative 12 GSE 2O synergistic activity. A nonlimiting example of an antimicro
Benzyl alcohol 33.3 bial composition containing the synergistic combination
Zemea (R) 33.3 includes from about 0.5 to about 10% (w/w) benzyl alcohol
Lactic acid 13.3
Preservative 15B GSE 14.3
and from about 0.2 to about 4% (w/w) fruit acids which
Zemea (R) 35.7 include but are not limited to lactic acid, citric acid, plant
Benzyl alcohol 35.7 based benzoic acid, and combinations thereof. These compo
Lactic acid 14.3 sitions exhibit broad spectrum and persistent activity at a pH
range from about 3.0 to about 6.0, preferably from about 3.0
to about 5.0.
0080. In preferred non-limiting examples of the invention, I0083. In addition to the above ingredients, a composition
an anti-inflammatory may be optionally added to the formu of the invention may optionally further comprise an emollient
lation. For example, tetrahydrocurcuminoid (THC) may be to further reduce irritation, such as, but not limited to, a fatty
added to the formulation.
alcohol, behentrimonium methosulfate-cetyl alcohol (Incro
TABLE 3
quat TMS), or a polyol such as glycerol, propylene glycol,
diglycerol, ethylene glycol, diethylene glycol, triethylene
% ww in glycol, dipropylene glycol, tripropylene glycol, hexylene gly
Preservative ngredient stock col, butylene glycol, etc.
Preservative 15 GSE 14.3 0084 Essential oils are volatile and therefore it is desirable
Lactic acid 14.3 that the antimicrobial composition containing essential oils is
Zemea (R)
Benzyl alcoho
35.7
35.7
incorporated in a suitable base in which it is stable at higher
Preservative 16 GSE 13.3
temperature and over a long period of time. Accordingly, a
Lactic acid 13.3 composition of the invention may optionally comprise a
Zemea (R) 33.3 hydrophilic or hydrophobic gel forming polymer, a fatty acid,
Benzyl alcoho 37.3 a plant oil, etc. Suitable hydrophilic gel polymers include, but
etrahydro curcuminoid 2.8 are not limited to, hydroxypropylmethyl cellulose, cationic
Preservative 17 Lactic acid 16.1
Zemea (R) 40.3 hydroxyethyl cellulose (U-care polymers), ethyl cellulose,
Benzyl alcoho 40.3 hydroxypropyl cellulose, hydroxymethyl cellulose, carboxy
Preservative 22
etrahydro curcuminoid
GSE
3.23
2O
methyl cellulose, polyethylene oxide (polyox resins), and
Zemea (R) 25
chitosan pyrrolidone carboxylate (Kytamer PC), silica gel.
Benzyl alcoho 50 carbomerpolymers etc. Suitable hydrophobic gel polymers
Tetrahydro curcuminoids S.O include, but are not limited to, silicone polymers, for example
Preservative 23 GSE
Zemea (R)
16.7
20.8
polydimethylsiloxane polymer (Dow Corning 225 Silicone
Benzyl alcoho 41.6 Fluid), dimethiconol fluid in dimethicone (Dow Corning
Lactic acid 16.7 1403 Silicone Fluid), cyclomethicone and dimethicone
Tetrahydro curcuminoids 4.2 copolyl (Dow Corning 3225C and Q2-5220 Silicone Fluid),
silicone glycol (BASF 1066 DCG polyol), KSG series Sili
cone gels (Shin-etsu), and combinations thereof. Suitable
0081. In non-limiting examples of the present invention, plant oils include, but are not limited to, olive oil, almond oil,
benzyl alcohol is combined with GSE, Zemea R, lemongrass avocado oil, basil oil, primrose oil, peanut oil, safflower oil,
oil, and lactic acid. sesame oil, Soya or soybean oil, wheat germ oil.
US 2012/020 1902 A1 Aug. 9, 2012

0085. The compositions of the present invention may tanol, ethanol, phenoxyethanol, phenylethyl alcohol. 2,4-
optionally further contain other botanicals or synthetic anti dichlorobenzyl alcohol, thiomersal, clindamycin,
microbial compounds. Exemplary but non-limiting antimi erythromycin, benzoyl peroxide, mupirocin, bacitracin, poly
crobials may include synthetic antimicrobial agents such as myxin B, neomycin, triclosan, parachlorometaxylene, foscar
quaternary ammonium compounds such as benzalkonium net, miconazole, fluconazole, itriconazole, ketoconazole, and
chloride and/or benzethonium chloride, biguanides, chlo pharmaceutically acceptable salts thereof. Additional antimi
rhexidine, polyhydroxymethylbiguanide (PHMB), Vantocil crobial agents may be used in the present compositions.
(polyiminoimidocarbonyliminoimidocarbonyl-iminohex 0091 Pharmaceutically acceptable chlorhexidine salts
amethylene)hydro-chloride, chlorinated phenols (Triclosan, that may be used as antimicrobial agents according to the
PCMX (Para Chloro Meta Xylenol), propanediol and their invention include, but are not limited to, chlorhexidine palmi
derivatives, iodine compounds, silver salts, and antifungal tate, chlorhexidine diphosphanilate, chlorhexidine diglucon
agents such as miconazole. Concentrations range from about ate, chlorhexidine diacetate, chlorhexidine dihydrochloride,
0% to about 10% (w/w), preferably from about 0% to about chlorhexidine dichloride, chlorhexidine dihydroiodide, chlo
5% (w/w), more preferably from about 0% to about 2% rhexidine diperchlorate, chlorhexidine dinitrate, chlorhexi
(w/w). dine sulfate, chlorhexidine sulfite, chlorhexidine thiosulfate,
chlorhexidine di-acid phosphate, chlorhexidine difluoro
4.7 Silver and Silver Salts phosphate, chlorhexidine diformate, chlorhexidine dipropi
I0086. The silver component of the invention may be onate, chlorhexidine di-iodobutyrate, chlorhexidine di-n-val
elemental silver or a silver salt. Suitable silver salts include erate, chlorhexidine dicaproate, chlorhexidine malonate,
silver acetate, silver benzoate, silver carbonate, silver iodate, chlorhexidine succinate, chlorhexidine malate, chlorhexidine
silver iodide, silverlactate, silver laurate, silver nitrate, silver tartrate, chlorhexidine dimonoglycolate, chlorhexidine
oxide, silver palmitate, silver protein and silver Sulfadiazine. monodiglycolate, chlorhexidine dilactate, chlorhexidine di-.
0087. Non-limiting examples of silver salts include silver alpha.-hydroxyisobutyrate, chlorhexidine diglucoheptonate,
Sulfadiazine in an amount ranging from about 0.5 to about 1% chlorhexidine di-isothionate, chlorhexidine dibenzoate, chlo
W/w, silver nitrate in an amount ranging from about 0.2 to rhexidine dicinnamate, chlorhexidine dimandelate, chlo
about 0.5% w/w, silver carbonate in an amount ranging from rhexidine di-isophthalate, chlorhexidine di-2-hydrox
about 0.2 to about 0.5% w/w, and silver oxide in an amount ynapthoate, and chlorhexidine embonate. Chlorhexidine free
ranging from about 0.2 to about 0.5% w/w. The preferred base is a further example of an antimicrobial agent. These and
compound for use as the silver component is silver sulfadi further examples of antimicrobial agents useful in this inven
tion can be found in Such references as Goodman and Gil
azine (AgSD). man's The Pharmacological Basis of Therapeutics (Goodman
4.8 Zinc and Zinc Salts Gilman A. Rall TW. Nies AS, Taylor P. ed. (Pergamon Press:
Elmsford, N.Y.: 1990)), the contents of which are hereby
0088 Suitable zinc salts for use in these formulations incorporated by reference.
include zinc acetate (molar solubility in water of 1.64 moles/ 0092. In preferred embodiments of the invention, the anti
1), Zinc butyrate (molar solubility in water of 0.4 moles/1), Zinc microbials include biguanides (chlorhexidine or polyhexam
citrate (molar solubility in water of <0.1 moles/1), Zinc glu ethelene biguanide), phenoxyethanol, miconazole, poly
conate (molar solubility in water of 0.28 moles/l), Zinc glyc mixin, neomycin, bacitracin and povidone iodine. Such
erate (moderately water soluble), Zinc glycolate (moderately antimicrobials are used in amounts ranging from about 0.1 to
water soluble), Zinc formate (molar solubility in water of 0.33 about 2.0% w/w.
moles/1), Zinc lactate (molar solubility in water of 0.17 moles/
1), Zinc picolinate (moderately water Soluble), Zinc propionate 4.10 Synergistic Combinations of Benzyl Alcohol
(molar solubility in water of 1.51 moles/1), Zinc salicylate and Alkanediols
(low water solubility), Zinc tartrate (moderately water 0093. In non-limiting embodiments, bifunctional alcohols
soluble) and Zinc undecylenate (moderately water soluble). which may be used according to the present invention are
0089 Combinations of zinc salts may be used, as soluble alkanediols. Suitable alkanediols include, but are not limited
and nonsoluble salts. Zinc salts are used in amounts ranging to, 1.3 propanediol, dodecanediol, decanediol, nonanediol.
from about 0.2 to about 1% w/w.
octanediol, heptanediol, hexanediol and pentanediol. In par
4.9 Antimicrobials ticular non-limiting embodiments, the alkanediols have a car
bon backbone of between 3 and 25 carbon atoms, including
0090. Various embodiments of the invention may com but not limited to 19 Nonanediol, 1,2-Decanediol, 1,10-De
prise one or more antimicrobial agent. Non-limiting canediol, 1,11-Undecanediol, 1,2-Dodecanediol, 1, 12 Dode
examples of antimicrobial agents include, but are not limited canediol, Cyclododecanediol. 1,13-Tridecanediol, 1.2-Tet
to, chlorhexidine gluconate (CHG), benzalkonium chloride radecanediol, 1,14-Tetradecanediol, 1,15-Pentadecanediol,
(BZK), or iodopropynylbutyl carbamate (IPBC: Germall 1,16-Hexadecanediol. 1,17-Heptadecanediol, 1,18-Octade
plus). Further examples of antimicrobial agents include, but canediol, 1,19-Nonadecanediol, 120-Eicosanediol, 1.21-He
are not limited to, iodophors, iodine, benzoic acid, dihy neicosanediol. 1.22-Docosanediol. 1.23-Tricosanediol. 1.24
droacetic acid, propionic acid, Sorbic acid, methyl paraben, Tetracosanediol, 1,25-Pentacosanediol.
ethyl paraben, propyl paraben, butyl paraben, cetrimide, qua 0094. In a preferred non-limiting embodiment, the
ternary ammonium compounds, including but not limited to alkanediol is 1.3 propanediol (ZemeaR), which is a natural
benzethonium chloride (BZT), dequalinium chloride, bigu product prepared from corn Sugar. In another non-limiting
anides such as chlorhexidine (including free base and salts embodiment, the alkanediols include 1.3 propanediol.
(see below)), PHMB (polyhexamethylene biguanide), ehlo octanediol and decanediol, and mixtures thereof. The
roeresol, chlorXylenol, benzyl alcohol, bronopol, chlorbu alkanediols are present in amounts ranging from about 0.2 to
US 2012/020 1902 A1 Aug. 9, 2012

about 1% w/w. In preferred embodiments the benzyl alcohol limited to oral products such as mouth rinse, toothpaste, and
may be prepared from a natural Source such as the Casia plant. dental floss coatings, veterinary and pet care products, pre
0095. In various non-limiting embodiments, the composi servative compositions, and Surface disinfectants including
tions of the present invention may include a solvent including Solutions, sprays or wipes.
but not limited to water, alcohols, glycols, glycerol, glycerine, 0100 Personal care compositions according to the inven
octoxyglycerine, diglycerol, propylene glycol, dipropylene tion, in addition to botanical extract, Solvent, and alkanediol.
glycol, and vegetable oils. Non-limiting examples of non may further comprise one or (preferably) more than one com
alkanediol alcohols for solubilisation are aliphatic alcohols ponent selected from the group consisting of emollients, sta
having carbon atoms about 1 to 8 Such as methanol, ethanol, bilizing agents, thickening agents, humectants, anti-inflam
n-propanol, isopropyl alcohol, 2-methyl-2 propanol, hexanol, matory agents, antimicrobial agents, neutralizing agents,
or combinations thereof. Aromatic alcohols, for example, but Surfactants, water, silicone polymers, alcohols, and hydro
not by way of limitation, phenoxyethanol, benzyl alcohol, gels, as well as additional components as may be known in the
1-phenoxy-2-propanol, and/or phenethyl alcohol, may also art. Non-limiting examples of Such components are set forth
optionally be used in combination with aliphatic alcohols. below.
aromatic alcohols, for example, but not by way of limitation, 0101. In various non-limiting embodiments of the inven
include phenoxyethanol, benzyl alcohol. 1-phenoxy-2pro tion, a personal care product comprising a combination of one
panol, and/or phenethyl alcohol, for example at a concentra or more essential oil and/or IC together with one or more fruit
tion of between about 0.5 and 5 percent (weight/weight) may acid may further comprise an emollient, for example PEG 20
also optionally be used in combination with aliphatic alco almond glycerides, Probutyl DB-10, Glucam P-20. Glucam
hols. A further solvent which optionally may be comprised in E-10, Glucam P-10, Glucam E-20, Glucam P-20 distearate,
a composition of the invention is iso propyl myristate. Addi glycerin, propylene glycol, Octoxyglycerin, cetyl acetate,
tional aliphatic alcohols include ethanol, denatured alcohol acetylated lanolin alcohol (e.g., Acetulan), cetyl ether (e.g.,
(SDA 40B and SDA 3C) and isopropanol. A preferred non PPG-10), myristyril ether (e.g., PPG-3), hydroxylated milk
limiting solvent is benzyl alcohol, which is used in amounts glycerides (e.g., Cremeral HMG), polyduaternium com
ranging from about 0.5 to about 5% w/w. pounds (e.g., U-care compounds), copolymers of dimethyl
4.11 Personal Care Products
dialyl ammonium chloride and acrylic acid (e.g., Merquat),
dipropylene glycol methyl ethers (e.g., Dowanol DPM, Dow
0096. The compositions of the invention may be used as Corning), polypropylene glycol ethers (e.g., Ucon 50-HB
alternatives to conventional preservatives or may be com 600, Union Carbide) and silicon polymers. Other suitable
bined with one or more antimicrobial agent to enhance their emollients may include hydrocarbon-based emollients such
activity, particularly providing persistent antimicrobial pro as petrolatum or mineral oil, fatty ester-based emollients,
tection without causing skin sensitivity. Such as methyl, isopropyl and butyl esters of fatty acids Such
0097. In non-limiting embodiments, the present invention as isopropyl palmitate, isopropyl myristate, isopropyl isos
provides for personal care product compositions comprising tearate, isostearyl isostearate, diisopropyl sebacate, and pro
low concentrations of one or more essential oil and/or one or pylene dipelargonate, 2-ethylhexyl isomonoate, 2-ethylhexyl
more botanical extract, for example a plant or fruit extract, in Stearate, C-C fatty alcohol lactates such as cetyl lactate
combination with one or more solvent and one or more and lauryl lactate, isopropyllanolate, 2-ethylhexyl salicylate,
alkanediol. In preferred, non-limiting embodiments, the cetyl myristate, oleyl myristate, oleyl Stearate, oleyl oleate,
above-listed components produce a synergistic antimicrobial hexyl laurate, and isohexyl laurate. Additional useful emol
effect, and the low concentrations of the active agents are Such lients include lanolin, olive oil, cocoa butter, and shea butter.
that regular exposure of skinto the personal care product does 0102. In various non-limiting embodiments of the inven
not produce skin irritation in a normal subject. Preferably, the tion, a personal care product comprising a combination of one
pH of personal care products is between about 3.0 and 6.0. or more essential oil and/or IC together with one or more fruit
0098. Non-limiting examples of personal care products acid may further comprise a stabilizing agent consisting of
which may utilize the invention include bar soap, liquid Soap antioxidants, including but not limited to vitamin C (ascorbic
(e.g., hand Soap), hand sanitizer (including rinse off and acid) and vitamin E (tocopherol), and Surfactants, including
leave-on alcohol based and aqueous-based hand disinfec but not limited to incromide or silicone-based surfactants
tants), preoperative skin disinfectant, cleansing (Masil SF-19, BASF).
0099 wipes, disinfecting wipes, body wash, acne treat 0103) In various non-limiting embodiments of the inven
ment products, antifungal diaper rash cream, antifungal skin tion, a personal care product comprising a combination of one
cream, shampoo, conditioner, cosmetics (including but not or more essential oil and/or IC together with one or more fruit
limited to liquid or powder foundation, liquid or Solid eye acid may further comprise a thickening and/or gelling agent
liner, mascara, cream eye shadow, tinted powder, “pancake” Such as Stearyl alcohol, cationic hydroxy ethyl cellulose
type powder to be used dry or moistened, etc.) deodorant, (Ucare; JR30), hydroxy propyl methyl cellulose, hydroxy
antimicrobial creams, body lotion, hand cream, topical propyl cellulose (Klucel), chitosan pyrrolidone carboxylate
cream, aftershave lotion, skin toner, mouth wash, toothpaste, (Kytamer), behenyl alcohol, Zinc Stearate, emulsifying
Sunscreen lotion, and baby products such as, but not limited waxes, including but not limited to Incroquatand Polawax, an
to, cleansing wipes, baby shampoo, baby Soap, and diaper addition polymer of acrylic acid, a resin Such as Carbopol R.
cream. The present invention may also be applied to wound ETDTTM 2020, guar gum, acacia, acrylates/steareth-20 meth
care items, such as, but not limited to, wound healing oint acrylate copolymer, agar, algin, alginic acid, ammonium
ments, creams, and lotions, wound coverings, burn wound acrylate co-polymers, ammonium alginate, ammonium chlo
cream, bandages, tape, and steri-Strips, and medical articles ride, ammonium sulfate, amylopectin, attapulgite, bentonite,
Such as medical gowns, caps, face masks, and shoe-covers, C9-15 alcohols, calcium acetate, calcium alginate, calcium
Surgical drops, etc. Additional products include but are not carrageenan, calcium chloride, caprylic alcohol, carbomer
US 2012/020 1902 A1 Aug. 9, 2012

910, carbomer 934, carbomer 934P, carbomer 940, carbomer decene copolymer, rice bran wax, Stearlkonium bentonite,
941, carboxymethyl hydroxyethyl cellulose, carboxymethyl Stearalkonium hectorite, Stearamide, Stearamide DEA-dis
hydroxypropyl guar, carrageenan, cellulose, cellulose gum, tearate, stearamide DIBA-stearate, stearamide MEA-stear
cetearyl alcohol, cetyl alcohol, corn starch, damar, dextrin, ate, Stearone, Stearyl erucamide, Stearyl Stearate, Stearyl
dibenzlidine sorbitol, ethylene dihydrogenated tallowamide, Stearoyl Stearate, synthetic beeswax, synthetic wax, trihy
ethylene diolamide, ethylene distearamide, gelatin, guar droxyStearin, trisononanoin, triisoStearin, tri-isoStearyl trili
gum, guar hydroxypropyltrimonium chloride, hectorite, noleate, trilaurin, trilinoleic acid, trilinolein, trimyristin, tri
hyaluronic acid, hydrated silica, hydroxybutyl methylcellu olein, tripalmitin, tristearin, Zinc laurate, Zinc myristate, Zinc
lose, hydroxyethylcellulose, hydroxyethyl ethylcellulose, neodecanoate, Zinc rosinate, and mixtures thereof. The gel
hydroxyethyl stearamide-MIPA, isocetyl alcohol, isostearyl ling agents used in vehicles may be natural gelling agents
alcohol, karayagum, kelp, lauryl alcohol, locust bean gum, Such as natural gums, starches, pectins, agar and gelatin.
magnesium aluminium silicate, magnesium silicate, magne Often, the gelling agents are based on polysaccharides or
sium trisilicate, methoxy PEG-22/dodecyl glycol copolymer, proteins Examples include but are not limited to guar gum,
methylcellulose, microcrystalline cellulose, montmorillo Xanthum gum, Alginic acid (E400), sodium alginate (E401),
nite, myristyl alcohol, oat flour, oleyl alcohol, palm kernel potassium alginate (E402), ammonium alginate (E403), cal
alcohol, pectin, PEG-2M, PEG-5M. polyacrylic acid, poly cium alginate (E404, polysaccharides from brown algae),
vinyl alcohol, potassium alginate, potassium aluminium Agar (E.406, a polysaccharide obtained from red seaweeds),
polyacrylate, potassium carrageenan, potassium chloride, Carrageenan (E407, a polysaccharide obtained from red sea
potassium sulfate, potato starch, propylene glycol alginate, weeds), Locustbean gum (E410, a natural gum from the seeds
Sodium acrylate/vinyl alcohol copolymer, Sodium carboxym of the Carob tree), Pectin (E440, a polysaccharide obtained
ethyl dextran, Sodium carrageenan, Sodium cellulose Sulfate, from apple or citrus-fruit), and Gelatin (E441, made by partial
Sodium chloride, sodium polymethacylate, Sodium silicoalu hydrolysis of animal collagen).
minate, sodium Sulfate, Stearalkonium bentotnite, Stearalko 0104. In various non-limiting embodiments of the inven
nium hectorite, stearyl alcohol, tallow alcohol, TEA-hydro tion, a personal care product comprising the combination of
chloride, tragacanth gum, tridecyl alcohol, tromethamine one or more botanical extract, Solvent, and alkanediol, may
magnesium aluminium silicate, wheat flour, wheat starch, further comprise a humectant, such as, for example, glycerin,
Xanthan gum, abietyl alcohol, acrylinoleic acid, aluminum 1-2-propylene glycol, dipropylene glycol, polyethylene gly
behenate, aluminum caprylate, aluminum dilinoleate, alumi col. 1,3-butylene glycol, or 12,6-hexanetriol.
num salts, such as distearate, and aluminum isostearates, 0105. In certain non-limiting embodiments of the inven
beeswax, behenamide, butadiene/acrylonitrile copolymer, tion, the antimicrobial effect of the inventive composition is
C29-70 acid, calcium behenate, calcium stearate, candelilla achieved by a composition consisting of the combination of
wax, carnauba, ceresin, cholesterol, cholesterol hydroxyS one or more botanical extract, solvent, and alkanediol, and
tearate, coconut alcohol, copal, diglyceryl Stearate malate, optionally with a fruit acid or anti-inflammatory. In alterna
dihydroabietyl alcohol, dimethyl lauramine oleate, dode tive embodiments of the invention, one or more additional
canoic acid/cetearyl alcohol/glycol copolymer, erucamide, antimicrobial agent may be comprised, for example, where
ethylcellulose, glyceryl triacetyl hydroxy Stearate, glyceryl Such antimicrobial agent may be selected from the group
tri-acetyl ricinolate, glycol dibelhenate, glycol di-octanoate, consisting of silver salts, iodophors, iodine, benzoic acid,
glycol distearate, hexanediol distearate, hydrogenated C6-14 dihydroacetic acid, propionic acid, Sorbic acid, methyl para
olefin polymers, hydrogenated castor oil, hydrogenated cot ben, ethyl paraben, propyl paraben, butyl paraben, cetrimide,
tonseed oil, hydrogenated lard, hydrogenated menhaden oil, benzalkonium chloride, dequalinium chloride, chlorhexi
hydrogenated palm kernel glycerides, hydrogenated palm dine, chloroeresol, chlorxylenol, benzyl alcohol, bronopol,
kernel oil, hydrogenated palm oil, hydrogenated poly chlorbutanol, phenoxyethanol, phenylethyl alcohol. 2,4-
isobutene, hydrogenated Soybean oil, hydrogenated tallow dichlorobenzyl alcohol, thiomersal, clindamycin, erythromy
amide, hydrogenated tallow glyceride, hydrogenated veg cin, benzoyl peroxide, mupirocin, bacitracin, polymyxin B,
etable glyceride, hydrogenated vegetable oil, Japan wax, neomycin, triclosan, parachlorometaxylene, foscarnet,
jojoba wax, lanolin alcohol, shea butter, lauramide, methyl miconazole, fluconazole, itriconazole, ketoconazole, silver
dehydroabietate, methyl hydrogenated rosinate, methyl rosi Sulfadiazine, octoxyglycerine, biguanides such as, but not
nate, methylstyrene/vinyltoluene copolymer, microcrystal limited to, chlorhexidine free base, chlorhexidine palmitate,
line wax, montan acid wax, montan wax, myristyleicosanol, chlorhexidine diphosphanilate, chlorhexidine digluconate,
myristyloctadecanol, octadecene/maleic anhyrdine copoly chlorhexidine diacetate, chlorhexidine dihydrochloride,
mer, octyldodecyl Stearoyl Stearate, oleamide, oleoStearine, chlorhexidine dichloride, chlorhexidine dihydroiodide, chlo
ouricury wax, oxidized polyethylene, oZokerite, paraffin, rhexidine diperchlorate, chlorhexidine dinitrate, chlorhexi
pentaerythrityl hydrogenated rosinate, pentaerythrity1 tet dine sulfate, chlorhexidine sulfite, chlorhexidine thiosulfate,
raoctanoate, pentaerythrityl rosinate, pentaerythrityl tetraabi chlorhexidine di-acid phosphate, chlorhexidine difluoro
etate, pentaerythrityl tetrabehenate, pentaerythrity1 tetra phosphate, chlorhexidine diformate, chlorhexidine dipropi
oleate, pentaerythrity1 tetrastearate, ophthalmic anhydride/ onate, chlorhexidine di-iodobutyrate, chlorhexidine di-n-val
glycerin/glycidyl decanoate copolymer, ophthalmic/ erate, chlorhexidine dicaproate, chlorhexidine malonate,
trimelitic/glycols copolymer, polybutene, polybutylene chlorhexidine succinate, chlorhexidine malate, chlorhexidine
terephthalate, polydipentene, polyethylene, polyisobutene, tartrate, chlorhexidine dimonoglycolate, chlorhexidine
polyisoprene, polyvinylbutyral, polyvinyl laurate, propylene monodiglycolate, chlorhexidine dilactate, chlorhexidine di
glycol dicaprylate, propylene glycol dicocoate, propylene C-hydroxyisobutyrate, chlorhexidine diglucoheptonate,
glycol disononanoate, propylene glycol dilaurate, propylene chlorhexidine di-isethionate, chlorhexidine dibenzoate, chlo
glycol dipelargonate, propylene glycol distearate, propylene rhexidine dicinnamate, chlorhexidine dimandelate, chlo
glycol diundecanoate, PVP/eiconsene copolymer, PVP/hexa rhexidine di-isophthalate, chlorhexidine di-2-hydrox
US 2012/020 1902 A1 Aug. 9, 2012

ynapthoate, chlorhexidine embonate, and prising a combination of one or more essential oil and/or IC
parahexamethylenebiguanide (“PHMB). together with one or more fruit acid may further comprise
0106. In various non-limiting embodiments of the inven additives such as dyes, fragrances, pH adjusters, including
tion, a personal care product comprising a combination of one basic pH adjusters such as ammonia, mono-, di- and tri-alkyl
or more essential oil and/or IC together with one or more fruit amines, mono-, di- and tri-alkanolamines, alkali metal and
acid may further comprise a neutralizing agent to neutralize alkaline earth metal hydroxides (e.g., ammonia, Sodium
carboxyl groups present in one or more other component, hydroxide, potassium hydroxide, lithium hydroxide, mono
Such as carboxyl groups in a thickening agent. Suitable neu ethanolamine, triethylamine, isopropylamine, diethanola
tralizing agents include diisopropylamine and triethanola mine and triethanolamine); acid pH adjusters such as mineral
mine. acids and polycarboxylic acids (e.g., hydrochloric acid, nitric
0107. In various non-limiting embodiments of the inven acid, phosphoric acid, Sulfuric acid, citric acid, glycolic acid,
tion, the compositions used in a personal care product may and lactic acid); Vitamins such as vitamin A, vitamin E and
further comprise a Surfactant. The Surfactant may be an Vitamin C; polyamino acids and salts, such as ethylenedi
anionic Surfactant, a cationic Surfactant, an ampholytic Sur amine tetraacidic acid (EDTA), preservatives such as Germall
factant, or a nonionic Surfactant. Examples of nonionic Sur plus and DMDM hydantoin, and Sunscreens such as ami
factants include polyethoxylates, fatty alcohols (e.g., ceteth
20 (acetyl ether of polyethylene oxide having an average of nobenzoic acid, arobenzone, cinoxate, dioxybenzone,
about 20 ethylene oxide units) and other “BRIJ”(R) nonionic homosalate, menthyl anthranilate, octocrylene, octyl meth
surfactants available from ICI Americas, Inc. (Wilmington, oxycinnamate, octyl salicylate, oxybenzoate, padimate O.
Del.)), cocamidopropyl betaine, alkyl phenols, fatty acid phenylbenzimidazole, Sulfonic acid, Sulisobenzone, titanium
esters of sorbitol, sorbitan, or polyoxyethylene sorbitan. Suit dioxide, trolamine Salicylate and Zinc oxide.
able anionic Surfactants include ammonium lauryl Sulfate and 0114. In one set of non-limiting embodiments, the present
lauryl ether Sulfo Succinate. invention provides for personal care compositions that are
0108. In various non-limiting embodiments of the inven antimicrobial and anti-inflammatory (AM-AI) compositions
tion, a personal care product may comprise water. for use in skin cleansers and topical creams. The following
0109. In various non-limiting embodiments of the inven Table provides a general formula for the AM-AI composi
tion, the compositions used in a personal care product may tions for skin cleanser.
further comprise a hydrogel comprising, for example, a com
pound such as hydroxypropylmethyl cellulose, cationic TABLE 5
hydroxyethyl cellulose (U-care polymers), ethyl cellulose,
hydroxypropyl cellulose, hydroxymethyl cellulose, carboxy Ingredients % in cleansers (ww)
methyl cellulose, polyethylene oxide (polyox resins), and GSE O.1-0.5
chitosan pyrrolidone carboxylate (Kytomer PC). Citric acid O-1.O
0110. In various non-limiting embodiments of the inven 1.3 propanediol O.S.-S.O
tion, a personal care product may further comprise an alcohol Benzyl alcohol O.25-S.O
Lemongrass oil O-O.S
or a mixture of alcohols, for example, ethanol, isopropyl Cinnamon oil O-O.S
alcohol, n-propyl alcohol, and mixtures thereof fatty alco Orange oil O-O.2
hols, including, but not limited to, cetyl alcohol, myristol TetraHydrocurcuminoids O-O.2
alcohol, Stearyl alcohol, octyl alcohol, decyl alcohol and lau Alkanediols (Pentanediol, O-1.O
Octanediol, Decanediol)
ryl alcohol, and mixtures thereof, and hexanol. Ethanol O-10
0111. In various non-limiting embodiments of the inven
tion, the compositions used in a personal care product may
further comprise a silicone polymer, for example one or more 0115 Specific examples of AM-AI skin cleanser formu
than one polydimethylsiloxane polymer (Dow Corning 225 lations are as follows.
Silicone Fluid), dimethiconol fluid in dimethicone (Dow
Corning 1403 Silicone Fluid), cyclomethicone and dimethi TABLE 6
cone copolyl (Dow Corning 3225C Silicone Fluid), and sili Ingredients
cone glycol (BASF 1066 DCG polyol). (% w/w) AM-AI - 7 AM-AI - 16 AM-AI - 17 AM-AI - 18
0112. In various non-limiting embodiments of the inven
tion, the compositions used in a personal care product com GSE
Lemongrass oil
O.2
O.3
O.2
O.3
O.S
O.3
O.S
O.3
prising a combination of one or more essential oil and/or IC Orange oil O.1 O.1 O.1 O.1
together with one or more fruit acid may further comprise an Benzyl alcohol O.S 1.O O.S 1.O
emollient solvent Such as a glycidyl ether having an alkyl Zemea (R) 1.O 1.O 1.O 1.O
chain up to and including 18 carbon molecules and ethoxy Citric acid
THC
1.O
O
1.O
O.15
1.O
O
1.O
O.15
lates and propoxylates thereof, a glyceryl ether having an Ethanol (SDA-3C) 4.9 4.25 4.6 3.95
alkyl chain up to and including 18 carbon molecules and
ethoxylates and propoxylates thereof, a mono- or diglyceryl
ether having an alkyl chain up to and including 18 carbon 0116. The present invention also provides for rapidly act
molecules and ethoxylates and propoxylates thereof, ethoxy ing AMI hand disinfectant lotions. The synergistic combina
late and propoxylate ethers, ethoxy diglycol esters, ethyl tion of GSE, Benzyl alcohol and 1.3 propanediol when used
hexyl alcohol propoxylate, and propylene glycol esther along with the anti inflammatory agent CRMN, edible plant
ethoxylates and propoxylates, and Arlamol (Alias). extract (Kefiprotect(R) and Pomegranate seed oil (PSO)
0113. In various non-limiting embodiments of the inven exhibits additional synergistic activity. The following Tables
tion, the compositions used in a personal care product com includes formulations for cleanser compositions.
US 2012/020 1902 A1 Aug. 9, 2012

TABLE 9A TABLE 11-continued

% (w.fw) % (w.fw) % (w.fw) Ingredients % (w.fw)
Ingredients HS-8 HS-9 HS-10
Grape seed extract O.2
GSE O.S O.S O.S Tetrahydrocucuminoid O.1
BA O.S O.S O.S Kefiprotect (R) O.1
Zemea TM O.S O.S O.S Zemea (R) 1.O
THC O.OS O.OS O.OS Lactic acid O.S
SDA 40-B 10.325 11.9S 11.95 Water 74.46
Natural alcohol AM-AI antifungal cream 3 White Petrolatum 4.0
Incroquat Behenyl O.S 1.O Stearyl Alcohol S.6
TMS Polyguaternium 10 O.24
U-care Jr 0.075 O.15 O.15 Inroquat Behenyl TMS 2.4
Arlasilk phospholipid O.S O.S Polowax NF 2.4
PTM Isopropyl Myristate 3.2
Hydroxypropyl O.15 Sorbitan Oleate 1.6
methylcellulose Polyoxyl 40 Stearate 1.6
(Methocel) Propylene Glycol 1.6
Water 87.55 84.85 85.7 Benzyl alcohol 1.O
Grape seed extract O.2
Tetrahydrocucuminoid O.15
0118. In specific, non-limiting embodiments, the present Lemongrass oil O.S
invention provides for the preparation of topical cream for Zemea (R)
Lactic acid
1.O
O.S
mulations containing anti-irritant, anti-inflammatory agents, Octanediol 1.O
gelling agents, and botanicals for minor cuts and wounds. Water 73.01
General and specific formulations for AM-AI compositions AM-AI antifungal cream 4 White Petrolatum 4.0
for topical creams follow below. Stearyl Alcohol S.6
Polyguaternium 10 O.24
Inroquat Behenyl TMS 2.4
TABLE 10 Polowax NF 2.4
Isopropyl Myristate 3.2
General formula % in cream (ww) Sorbitan Oleate 1.6
Polyoxyl 40 Stearate 1.6
GSE O.1-0.5 Propylene Glycol 1.6
Lactic acid O-O.S Benzyl alcohol 1.O
1.3 propanediol (Zemea (R) O5-10.O Grape seed extract O.2
Benzyl alcohol O.S.-S.O Tetrahydrocucuminoid O.15
Lemongrass oil O-O.S Lemongrass oil O.S
TetraHydrocurcuminoids O-O.2 Zemea (R) 1.O
Octoxyglyerin 1.O
Lactic acid O.S
0119 Antifungal activity of antifungal agents can be sig Water 73.01
nificantly enhanced by the use of synergistic combination of
alcohols such as benzyl alcohol, fruit acids, and optionally 0.120. The following Table provides a formulation for
biguanide and benzalkonium chloride. alcohol-based hand sanitizer compositions.
TABLE 11
TABLE 12
Ingredients % (w.fw)
Ingredients % in cleansers (wiw)
AM-AI antifungal cream 1 White Petrolatum 4.0
Stearyl Alcohol S.6 GSE O.1-0.5
Polyguaternium 10 O.24 Lactic acid O-O.S
Inroquat Behenyl TMS 2.4 1.3 propanediol (Zemea (R) O.S.-S.O
Polowax NF 2.4 Benzyl alcohol O.S.-S.O
Isopropyl Myristate 3.2 Lemongrass oil O-O.3
Sorbitan Oleate 1.6 Octoxyglycerin O-3.0
Polyoxyl 40 Stearate 1.6 Ethyl alcohol 40-70
Propylene Glycol 1.6 Water 1O-30
Benzyl alcohol 1.O TetraHydrocurcuminoids O-O.1
Grape seed extract O.2 Pomegranate oil O-O.1
Tetrahydrocucuminoid O.15
Zemea (R) 1.O
Phospholipid PTM O.S I0121 The present invention also provides formulations
Water 74S1 containing GSE, benzyl alcohol, ZemeaR), THC, and a coco
AM-AI antifungal cream 2 White Petrolatum 4.0 nut based phospholipid for alcohol-based hand sanitizer
Stearyl Alcohol S.6 (AHS) compositions.
Polyguaternium 10 O.24
Inroquat Behenyl TMS 2.4
Polowax NF 2.4 TABLE 13
Isopropyl Myristate 3.2
Sorbitan Oleate 1.6 Ingredients % (w.fw)
Polyoxyl 40 Stearate 1.6
Propylene Glycol 1.6 GSE 0.2-1.0
Benzyl alcohol 1.O Lactic acid O.2-2.O
US 2012/020 1902 A1 Aug. 9, 2012
13

TABLE 13-continued TABLE 15B-continued

Ingredients % (w.fw) Topical cream ingredients % (w.fw)
1.3 propanediol (Zemea (R) Lactic acid
Benzyl alcohol Water
Water
TetraHydrocurcuminoids
SDA 40-B natural alcohol 0.124 Provided below in Table 16A is a general formula
Incroquat Behenyl TMS tion for aqueous hand disinfectants containing benzyl alco
Polyguaternium 10
Arlasilk phopholipid PTM (coconut derived) hol, 1.3 propanediol, fruit acid, and botanicals.
SymsitiveTM 1609 (Symrise)
pH adjusted to 3.0-6.0 TABLE 1.6A
Ingredients % (w.fw)
0122) The following specific formulations were prepared. Botanical extract 0.-4.0
Benzyl alcohol O.5-4.O
TABLE 1.4 Aliphatic alcohol (C1-4) O-1O.O
Fruit acid (Lactic citric acid) 0.2-4.0
% (w.fw) % (w.fw) % (w.fw) % (w.fw) Alkylglycoside O-2O
Ingredients AHS-1 AHS-2 AHS-3 AHS-4 Polyguartenium 10 O-O.2
Hydroxyl propyl methyl cellulose O.O-O.3
GSE O.2 O.2 O.2 O.2 Water SO.O-900
Benzyl alcohol O.S O.S O.S O.S Glycerine O-S.O
Zemea (R) O.S O.S O.S O.S Benzoic acid O-1.O
Ethyl alcohol 67.2 67.2 67.2 67.2 Bisbolol + Ginger extract O-O.1
THC O.OS O.OS O.OS O.OS
Incroquat Behenyl TMS 1.O 1.O
Polyguaternium 10 O.1 O.1 O.1 O.1 0.125 Tables 16B and 16C provide additional general for
SymsitiveTM 1609 O.S O.S
(Symrise) mulations for aqueous leave on hand disinfectants.
Arlasilk phospholipid PTM 1.O 1.O 1.O 1.O
Hydroxypropyl O.OS O.OS TABLE 1.6B
methylcellulose (Methocel)
Water 3O4 29.9 29.45 28.95 ALHD1

Ingredients % w/w (Range)

(0123 The following formulations are for an topical cream Chlorhexidine gluconate O.10-0.2O
products. Polyhexamethylene Biguanide O.OO-O.30
Benzethonium chloride O.10-0.30
TABLE 1.5A Triclosan O.OO-1.OO
Incroquat Compounds O.10-100
AM-AI topical cream acne treatment Diglycerol O.OO-S.OO
Dipropylene glycol OSO-5.00
Ingredients % in cleansers (ww) Nonionic Pluronic surfactant O.1.0-2.OO
SDA 40B alcohol O.OO-2O.OO
GSE O. 1-0.5 Water 8O.OO-90.OO
Salicylic acid O.S.-3.0 Octanediol O.30-100
Lactic acid O-O.2 Salicylic acid O.OO
1.3 propanediol (Zemea (R) O.S.-S.O Salts of salicylic acid O.OO
Benzyl alcohol O.S.-S.O Essential oils O.OO
Cinnamon oil O. 1-0.3 Botanicals O.OO
Octoxyglycerin O-3.0 Benzyl alcohol O.OO
TetraHydrocurcuminoids O.04-0.2 Polyguaternium 10 O.10-0.2O
Polawax O.OO-1.OO
Cyclohexyl pentanol O.OO-1.OO
Lactic acid O.OO-O.30
TABLE 15B Phenoxyethanol O.OO-1.OO
(pH-3-5)
Topical cream ingredients % (w.fw)
Petrolatum 9.68
Stearyl alcohol 14.52 TABLE 16C
Isopropyl myristate 4.84
Sorbitan oleate 2.42 ALHD2
Polyoxy 40 stearate (Myri 52) 6.OS
Germal + O.3 Ingredients % w/w (Range)
Propylene glycol 4.0
Zinc lactate O.2 Polyhexamethylene O.OO-O.30
Zinc oxide O.3 Biguanide
Calendula oil 1.O Benzethonium chloride O.10-030
Silver sulfadiazine 1.O Incroquat compounds O.10-100
Benzyl alcohol O.S Diglycerol O.S.-S.OO
THC 0.075 Dipropylene glycol O-5.00
1.3 propanediol O.S Nonionic Surfactant O.10-2.00
US 2012/020 1902 A1 Aug. 9, 2012

TABLE 16C-continued TABLE 1.8

ALHD2 ngredients #22 #23 18LA 18LAK. 18LAKS

Ingredients % w/w (Range) Pomegranate O.2 O O O O

seed extract
SDA 40B alcohol O.OO-2O.OO Orsole O O.2 O O O
Water 8O.OO-9000 (rosemary
Alkanediol O.30-3.OO extract)
Kefiprotect O O O O.O24 1.O
Benzyl alcohol 2-SOO Grapefruit O O 2.0 2.0 2.0
Polyguaternium 10 O.10-030 seed extract
Polawax O.OO-10 Benzyl 2.O 2.0 O6 O.6 O.6
Fruit acids O.OO-2O alcohol
Benzoic acid and salt O.1-0.5 3 2.O 2.0 O6 O.6 O.6
Phenoxyethanol O.OO-1.OO Propanediol
Zinc gluconate O-O.2 Citric acid O O.2 O.2 O O
Zinc lactate O-O.2 Lactic acid O O O.2 O.2 O.2
Symrelief (Symrise) O-O.1 Glucopon 1.O 1.O O O 1.O
Aloe Juice O-1.O 215UP
SDA 4OB 7.0 7.0 9.0 9.0 8.O
(pH-3-5) Water 2.6 2.6 2.6 2.6 1.6
Base 26** 85.2 8S.O 84.8 84.976 85.0

0126 Tables 17A and 17B below provide exemplary, non ** Base26 contains 0.2% hydroxymethylpropyl cellulose and 0.2% polyguaternium10
limiting, formulations for aqueous hand disinfectants. I0128. A general formulation for a stock solution of aque
TABLE 17A ous hand disinfectant containing higher concentrations of
benzyl alcohol is provided below. The stock solution is used
Ingredients #18 #19 #2O #21 #29 in various personal care products in amounts ranging from
Pomegranate 2.0 1.O O O O
2.0-20% (w/w).
seed oil
Kefiprotect O O 2.0 1.O 4.0 TABLE 19
Benzyl alcohol 1.O 2.0 1.O 2.0 1.O
1.3 Propanediol 2.0 2.0 2.0 2.0 2.O Ingredients % (w.fw) Range
Citric acid O.2 O.2 O.2 O.2 O.2
Glucopon 1.O 1.O 1.O 1.O 1.O Botanical extract 10.0-2O.O
215UP Fruit acid O.5-4.0
SDA3C 8.8 8.8 8.8 8.8 7.0 Benzyl alcohol S.O-1O.O
Base 26** 8S.O 8S.O 85.0 8S.O 85.O Propanediol S.O-1O.O

*Mixture offermented oregano and thyme plant extracts

**Base 26 contains 0.2% hydroxymethylpropyl cellulose and 0.2% polyguatemium10 I0129. The Table below provides nonlimiting examples of
formulations of aqueous hand disinfectant containing higher
TABLE 17B
concentrations of benzyl alcohol.
% Wiw TABLE 20
ngredients #33 #33A Ingredients 18LA1 18LA2 37 37A

Benzethonium chloride O.20 O.20 Grapefruit seed 2.0 2.0 O 2.O

incroquat CTC 30 O.20 O.20 extract
Diglycerol S.OO S.OO Benzyl alcohol 1.O O6 2.0 2.O
3 Propanediol (Zemea) 3.0 3.0 1.3 Propanediol 1.O O6 3.0 3.0
Glucopon 215U O.20 O.20 Lactic acid O.2 O.2 2.0 2.O
Pentanediol 1.O 1.O Glucopon 215UP 1.O 1.O 1.O 1.O
Octanediol O.S O.S SDA3C 8.0 8.0 7.0 7.0
Water 79.25 79.25 Water 1.8 2.55 O O
Benzoic acid O.1 O.1 Symrelief O O.OS O O.OS
Sodium Benzoate O.1 O.1 Base26 8S.O 8S.O 85.0 82.95
Benzyl alcohol 2.0 2.O
SDA 40 Balcohol 7.0 7.0
Zinc gluconate O.10 O.1 0.130 Table 21 shows additional nonlimiting formulations
Zinc lactate
Polyguatemium-10
O.10
O.3
O.1
O.3
of aqueous hand disinfectants containing higher concentra
Hydroxypropul methyl O.20 O.2 tions of benzyl alcohol.
cellulose
Lactic acid O.20 O.OS TABLE 21
Symrelief O.OS O.S
Aloe barbadensis juice O.S Ingredients 18LA 4 18LAS 37B 1.8LA4-S 18LA6 18LA7
Grapefruit 1.O 1.O O.O 1.O 2.0 O.O
seed exrtract
0127. Additional nonlimiting formulations for aqueous Benzyl alcohol 2.0 2.0 2.0 2.0 2.0 2.0
hand disinfectants containing benzyl alcohol, 1.3 pro Kefiprotect O O O O O 2.0
panediol, and botanicals are provided below.
US 2012/020 1902 A1 Aug. 9, 2012

TABLE 21-continued TABLE 24A-continued

Ingredients 18LA 4 18LAS 37B 18LA4-S 18LA6 18LA7 Wash off hand cleansing soap 1
1.3 Propanediol 3.0 3.0 3.0 3.0 3.0 3.0 Ingredients % w/w grams
Lactic acid 2.0 2.O 2.0 2.O 2.0 2.0
Glucopon 1.O 1.O 1.O 1.O 1.O 1.O Dipropylene glycol O.OO-S.OO
215UP Nonionic Pluronic surfactant OSO-2.OO
SDA3C 6.O O O 6.0 1O.O 1O.O SDA 40B alcohol 1O.OO-2O.OO
Water O 6.0 7.0 O O O Water 40.OO-60.00
Base26 8S.O 85.O 8S.O 84.95 80.0 8O.O Octanediol O.OO-1.OO
Symrelief O O O O.OS O O Salicylic acid O.OO
Salts of salicylic acid O.OO
Essential oils O.OO
0131. A general formula for rapidly acting aqueous hand Botanicals O.OO
disinfectant containing synergistic combinations of benzyl Fruit acids O.OO-OOO
Benzyl alcohol O.OO-3.OO
alcohol, fruit acid, with or without benzalkonium chloride is ArlasikPTM O.OO-2.OO
provided below. Phenoxyethanol O.OO-1.OO
Polyguaternium10 O.1O-OSO
TABLE 22 Germal O.10-030
Incromine oxid L. S.OO-1S.OO
Ingredients % Range (pH 3-5)
Benzyl alcohol 10-5.O
1.3 Propanediol 10-5.O
Fruit acid O.2-2.O
Benzalkonium chloride O.O-O.12 TABLE 24B
Alcohol O.O-1O.O
Polyguartenium 10 O.O-O.2 Wash off hand cleansing Soap 2
Hydroxypropyl methyl O.O-O.3
cellulose Ingredients % w/w (Range)
Glycerine O.O-O.S Polyhexamethylene Biguanide O.OO-O.30
Symrelief (Bisbolol + O.O-O.1 Benzethonium chloride O.10-0.30
Ginger extract) Benzalkonium chloride O.OO-O.10
Water SO.O-900
Triclosan O.OO-1.O
Incroquat compounds O.1-0.50
Diglycerol OSO-5.00
0132) Nonlimiting exemplary formulations for composi Dipropylene glycol O.OO-S.OO
tions of aqueous hand disinfectants are provided below. Nonionic Pluronic surfactant OSO-2.OO
SDA 40B alcohol 1O.OO-2O.OO
TABLE 23 Water 4000-60.OO
Alkanediol O-100
Salicylic acid O.OO
Salts of salicylic acid O.OO
Ingredients 28 A. D 28B 28C Essential oils O.OO
Botanicals O.OO
Benzalkonium O.1 O.1 O.1 O.1 O.1 Benzyl alcohol 2.O-5.O
chloride Fruit acids O-2.O
Benzyl alcohol 3.0 3.0 O 3.0 3.0 Arlasik PTM O.OO-2.OO
1.3 propanediol 3.0 O O 4.0 4.0 Phenoxyethanol O.OO-1.OO
Citric acid O.2 O.2 O O O Polyguaternium10 O.10-0.50
Lactic acid O O O O.2 O.2 Germal O.10-0.30
SDA3C 7.0 7.0 7.0 7.0 7.0 Incromine oxide L. S.OO-1S.OO
Base26 84.9 8S.O 85.0 8S.O 8S.O Zinc gluconate O-O.2
Water 1.8 4.7 7.9 0.7 O.65 Zinc lactate O-O.2
Symreleif O O O O O.OS (pH 3-5)

0133. The following Tables 24A, 24B, and 24C summa

rize a general formulation for the compositions of hand dis TABLE 24C
infectant soaps. Ingredients % Range
TABLE 24A Benzyl alcohol 1.0-3.0
1.3 Propanediol 1.O-5.O
Wash off hand cleansing Soap 1 Fruitacid O.2-2.O
Triclosan O.O-O.S
Ingredients % w/w grams Biguanide O.O-O.S
Benzalkonium chloride 0.1-0.12
Chlorhexidine gluconate O.10-1.OO Benzethonium chloride O.O-O.18
Polyhexamethylene Biguanide O.OO-O.30 Phenoxyethanol O.O-1.O
Benzethonium chloride O.10-030 IncromineoxideL S.O-1S.O
Benzalkonium chloride O.OO-O.10 Montaline C 40 S.O-1O.O
Triclosan O.OO-1.OO Crosultane C 50 3.0-S.O
Incroquat Compounds O.10-1.OO Nonionic Surfactant O.S.-S.O
Diglycerol O.SO-S.OO Dipropylene glycol O.O-5.O
US 2012/020 1902 A1 Aug. 9, 2012
16

TABLE 24C-continued TABLE 27-continued

Ingredients % Range % (w.fw
Diglycerol O.O-5.O ABHS - ABHS
Glycerine O.O-5.O ngredients A-4 B-4 C-4 D-4 E-4 5 6
Water 400-800
Lactic acid 2.O O.2 O.2 O.2 O O O
Grape fruit O.2 O.2 O O O O O
Table 25 provides certain nonlimiting exemplary formula- seed extract
tions of hand disinfectant Soaps. Chlorhexidine
gluconate O O O2 O O O O
Polyhexamethyl O O O O O O.3 O.3
TABLE 25 biguanide
(PHMB)
96(ww.) Octanediol O O O O.S O.S O O
Lactic acid O O O O O.2 O.2 2.0
14 15 16 14 SDA3C alcohol 67.2 67.2 67.2 67.2 67.2 67.2 67.2
ngredients (BPC) 14Tc 14BZT (Tc) (Citric) (BZK) Water 28.2 30 30 29.7 29.7 27.9 26.OS
Polyguartenium O.2 O.2 O.2 O.2 O.2 O.2 O.2
Citric acid 1.O 1.O 1.O 1.O 1.O 1.O O
Benzyl alcohol 2.0 2.0 2.0 2.O O 2.0 Hydroxypropyl O.2 O.2 O.2 O.2 O.2 O.2 O.2
Propane diol 1.O 1.O 1.O 1.O O 1.O methy cellulose
Phenoxy ethanol 1.O 1.O 1.O 1.O O 1.O Symrelief O O O O O O O.OS
SDA 40 B 10 10 10 10 10 10
Triclosan O O.15 O O.15 O O
Benzethonium O O O.18 O O O Table 28 provides a general formula for the compositions
chloride
Benzalkonium O O O O O O.1 containing9. benzV1
y alcohol. propaned1ol,
pro diol. and
and lactic
lacuc acid
ac1d.
chloride
Water 58 57.85 57.82 57.85 62 57.9 TABLE 28
incromine oxide 13 13 13 13 13 13
Montalene 5 5 5 5 5 5 Ingredients % Wiw
Dipropylene 5 5 5 5 5 5
glycol Aliphatic alcohol (C1-6) 60-70
Crosultane C-50 3 3 3 3 3 3 Hydroxy propyl cellulose O.5-1.O
Pronic F 87 NF 1 1 1 1 1 1 Incroquat Behenyl TMS 50 0.2-1.0
Benzyl alcohol 1.O-5.O
1.3 Propanediol 1.O-5.O
0134. In certain embodiments of the invention, the general Glycerine 1.O-5.O
formula for alcohol-based hand disinfectants is as follows. Water
Lactic acid
S.O-2O.O
O.2-2.O
Benzoic acid O-10
TABLE 26 Incromine oxide L. 3.0-10
Pronic F87 NF OS-2.O
Ingredients % Wiw Cocoamidopropyl betaine S.O-1O.O
Masi SF 19 OS-2.O
Benzyl alcohol 1-5 Aloe barbadensis Juice O.S-20
1.3 propanediol (Zemea) 1-5 Symrelief O-O.1
Lactic acid 0.2-4
Benzoic acid O-2
EON
ornex1dine gluconate
i-vy.2 Table 29 provides nonlimiting formulations for the alcohol
Polyhexamethylbiguanide O-O.3 based, wash-off, hand disinfectants.
(PHMB)
Octanediol O-1.O TABLE 29
Aliphatic Alcohol 60-70
Water 20-30 ngredients 2A 2B 2C 2D
Polyguartenium 10 O.1-0.3
Hydroxypropyl methy O.1-0.3 SDA 40 B 64.84 64.84 64.84 64.84
cellulose Klucel O.S O.S O.S O.S
Symrelief O-O.1 Benzyl alcohol 2.0 2.O 2.0 2.O
Aloe barbadensis juice O-1.O 3 Propanediol 2.0 3.0 2.0 S.O
Phenoxyethanol 1.O 1.O 1.O 1.O
Glycerine 1.O 1.O 3.0 3.0
Table 27 provides for specific nonlimiting examples of com- Water 10.66 9.66 6.56 3.56
positions of alcohol-based hand disinfectants Citric acid
incromine oxide
1.O
8.0
1.O
8.0
1.O
8.0
1.O
8.0

TABLE 27 Pronic F87 NF 1.O 1.O 1.O 1.O

Cocamidopropyl 8.0 8.0 8.0 8.0
96 (WW) betaine
Masi SF 19 1.O 1.O
ABHS - ABHS- Aloe 1.O 1.O
Ingredients A-4 B-4 C-4 D-4 E-4 5 6 barbadensis
lCC
Benzyl alcohol 1 1 1 1 1 1 1 Symrelief O.1 O.1
Zemea 1 1 1 1 1 3 3
US 2012/020 1902 A1 Aug. 9, 2012
17

0135. The following Tables 30A and 30B provides non- 0.136 Table 31 provides a composition of an alcohol based
limiting examples of alcohol-based compositions for wash- broad spectrum rapidly acting wash off hand disinfectant
off hand disinfectant, and wash off hand cleansing specific (ABHS 5-E).
soaps (3E and 3G).
TABLE 31
TABLE 3OA
ngredients 3C 3D 4C 4D SC SD ABHS 5-E Ingredients % Wiw

B s s s s 64.84 64.84 SDA 40 B 64.84

Ce
KM O.3 O.3 O.3 O.3 Hydroxy propyl cellulose 1.O
Polyguartenium10 O.2 O.2 Incroquat Behenyl TMS 50 O.S
Benzyl alcohol 2.O 2.0 2.0 2.0 2.0 2.0 Benzyl alcohol 2.0
3 Propanediol 2.O S.O 2.0 S.O 2.0 S.O
Phenoxyethanol O O 1.O. 10 1.O 1.0 13 Propanediol S.O
Glycerine 3.0 3.0 3.0 3.0 3.0 3.0 Glycerine 3.0
Water 6.06 3.06 6.26 3.26 6.56 3.56 Water 6.56
Citric acid O O 1.O 1.O 1.O 1.O Lactic acid 1.O
incromine oxide L. 8.0 8.0 8.0 8.0 8.0 8.O
Pronic F87 NF O O 1.O. 10 1.O 1.0 Incromine oxide L. S.O
Cocamidopropyl 8.0 8.0 8.0 8.0 8.0 8.O Pronic F87 NF 1.O
Beataine Cocoamidopropyl betaine 8.0
Masi SF 19 O O 1.O 1.O 1.O 1.O Masi SF 19 1.O
Aloe barbadensis O O 1.O 1.O 1.O 1.O Aloe barbadensis Juice 1.O
lCC Symrelief O.1
Symrelief O.1 O.1 O.1 O.1 O.1 O.1

TABLE 3OB
Table 32 provides a formulation for antifungal skin cream 27.
Wash Off Hand Cleansing TABLE 32
Specific Soaps 1. Water 6S.O2
% Wiw 2. Zinc gluconate O.10
3. Polyguartenium 10 O.24
ngredients 3E 3G 4. Incroquat Behenyl TMS 3.2
5. Polawax 3.2
PHMB O.30 O.30 6. Petroleum Jelly 4.7
Benzethonium chloride O16 O.20 7. Steary alcohol 7.4
Benzalkonium chloride O.O7 O.OO 8. Myri 52. 2.8
Triclosan O.15 O.OO 9. Zinc Oxide O.2O
(ncroquat behenyl TMS O.30 O.30 10. Propylene Glycol 2.0
Diglycerol 3.00 3.00 11. Isopropyl Myristate 3.30
Pronic F87 Pri 1.00 1.OO 12. Sorbitan Oleate 1...SO
SDA40 Balcohol 12.00 12.00 13. Miconazole 2.0
Water 68.12 67.92 14. Dipropyleneglycol 2.0
Octanediol O.SO 1.OO 15. Benzyl alcohol O.8
Polyguaternium 10 O.20 O.20 16. 1.3 Propanediol (Zemea) O.S
Germal O.20 O.20 17. Tetrahydrocurcuminoid O.OS
incromone oxide L. 8.00 8.OO 18. Octanediol O.S
Montalene C-40 S.OO S.OO 19. Lactic acid (88% active) O.2
Arlasilk phospholipid 1.00 O.OO 20. Benzalkonium chloride (Powder) O.09
PTM 21. Chlorhexidine gluconate O.2
Phenoxy ethanol O.OO 1.OO
Benzyl alcohol O.OO 2.OO
Lactic acid O.OO O.20 0.137 In certain embodiments of the invention, the com
Zinc gluconate O.OO O.20
Zinc lactate O.OO O.10 positions are used in antifungal diaper rash creams. The fol
lowing Table provides nonlimiting examples of Such formu
lations.

TABLE 33
Ingredients 28S 29S 30 31A 31B 32 33A 33B

Water 49.21 43.21 41.85 36.15 36.25 41.8

Zinc gluconate O.10 O.1 O.1 O.2 O.2 O.2 0.4 0.4
Polyguartenium 10 O.24 O.24
Incroquat Behenyl TMS 3.2 3.2 3.6
Polawax 3.2 3.2
Mineral oil 2.O
White petrolatum - 11.O. 11.O 1 O.O 47.OS 46.95
Petroleum Jelly 4.7 S.6 S.6
US 2012/020 1902 A1 Aug. 9, 2012
18

TABLE 33-continued
Ingredients 28S 29S 3O 31A 31B 32 33A 33B
Stearyl alcohol 7.4 8.9 8.9 16.O. 16.0 9.0 16.O 16.O
Myri 52 PolyoxylAO) 2.8 3.4 3.4 6.7 6.7 6.5 6.7 6.7
Zinc Oxide 3.0 S.O 1.O.O. 10.O. 10.O SO 10.O 1 O.O
Propylene Glycol 2.O 2.O 2.O
Isopropyl Myristate 3.30 4.0 6.O 6.O 6.O 6.O 6.O
Sorbitan Oleate 1...SO 1.8 2.7 2.7 2.7 2.7 2.7
Cetearyl alcohol 4.4
Popyleneglycol S.O
Zinc stearate 2.O 2.O 2.O 4.0 4.0 4.0 4.O 4.0
Miconazole 2.O 2.O 2.O 2.0 2.0 2.0 2.O 2.0
Dipropyleneglycol 2.O 2.O 2.O
Benzyl alcohol O.8 O.8 O.8 1.O 1.O O.8 1.O 1.O
1.3 Propanediol (Zemea) O.S O.S O.S 3.0 3.0 O.S 3.0 3.0
Tetrahydrocurcuminoid O.OS O.OS O.OS O.OS O.OS O.OS O.OS O.OS
Octanediol O.S O.S O.S
Lactic acid (88% active) O.2 O.2 O.2 1.O 1.O O.2 1.O 1.O
Benzalkonium chloride O.1 O.1 O.1 O.1 O.1 O.1
(Powder)
Chlorhexidine gluconate O.2 0.2x O.2 O.2 O.2
Calendatia oil 1.O 1.O 1.O 1.O
Silicone D C 1403 S.O S.O — 5.0
Silicone D C 3225 C S.O S.O — 5.0
Butyleneglycol 2.O
Sorbitan Oleate 1.8

0.138. The compositions of the present invention may also

be used in anti-bacterial first aid cream. The following table TABLE 35
provides a nonlimiting examples of a formulation used in first
aid creams. % Wiw

TABLE 34 ngredients A. A3 A4 AS

ngredients % (w.fw) Water 72.84 67.84 67.84 67.84

Polyguartemium 10 O.24 O.24 O.24 O.24
2N. t es 3. incroquat Behenyl TMS 240 2.40 240 2.40
in Nin 10 0.34 Polawax 240 2.40 240 2.40
(ncroquat Behenyl TMS 3.2 Petroleum Jelly 4.OO 4.OO 4.OO 4.OO
Polawax 3.2 Stearyl alcohol S.61 S.61 S.61 S.61
Petroleum Jelly 4.7 Propylene glycol 1.60 1.60 1.60 1.60
Salcohol s Sopropyl myristate 3.21 3.21 3.21 3.21
A oxide 0.50 Sorbitan Oleate 1.60 1.60 1.60 1.60
Propylene Glycol 2.0 Myri 52 1.60 1.60 1.60 1.60
sopropyl Myristate 3.30 Pomegranate seed oil O.2 O.2 O.2 O.2
Sorbitan Oleate 1...SO Lactic acid O.2 O.2 O.2 O.2
Episyrol 3. Benzyl alcohol 2.0 2.O 2.0 2.O
enzyl alcono 3P diol 2.0 2.O 2.0 2.O
3 Propanediol (Zemea) O.S T ropanedio
Tetrahydrocurcuminoid O.OS etrahydrocurcuminoid O.1 O.1 O.1 O.1
Octanediol O.S Mineral oil 1.O 1.O 1.O
Lactic acid (88% active) O.2 Fermented soy protein 2.0
Calendula oil 1.O Resveratrol 2.O 2.0 2.O
Blonium chloride (Powder) 8. Glycerine 2.O 1.O
Aloe barbadensis Juice 1.O

0.139. The compositions of the present invention may also

be used in topical wound healing creams. The following Table 0140 Table 36 provides a nonlimiting examples of formu
provides nonlimiting examples of such formulations. lations for various compositions of oral care products.

TABLE 36
% (w.fw

Ingredients OCP1. OCP2 OCP3 OCP4 OCP5 OCP6 OCP7 OCP8 OCP9
Water 70.46 70.46 66.528 66.338 66.238 66.078 66.23S 76.737 76.587
Polyguaternium10 0.175 0.175 O O O O
US 2012/020 1902 A1 Aug. 9, 2012
19

TABLE 36-continued

Ingredients OCP1 OCP2 OCP3 OCP4 OCP5 OCP6 OCP7 OCP8 OCP.9

Hydroxypropul 0.175 0.175 O O O O

cellulose
Glycerin 10 10 10 10 10 10 10 10 10
Sodium saccharin O.08 O.08 O.O8 O.08 O.08 O.08 O.08 O.O8 O.08
Pluronic F127 O.3 O.3 O.3 O.3 O.3 O.3 O.3 O.3 O.3
Sorbic acid O.1 O.1 O O O O
Potassium sorbate O.1 O.1 O O O O
Spearmint oil O.O1 O.O1 O O O O
Zinc salicylate O.OS O.OS O O.OS O.OS O.OS O.OS O.OS O.OS
Copper salicylate O.O2S O.O2S O.O2S
Thymol O.OS O.OS O.OS O.OS O.OS O.OS O.064 O.O64 O.064
Menthol O O O.04 O.04 O.04 O.04 O.04 O.04 O.04
Eucalyptol O O O.O92 O.O92 O.092 O.O92 O.092 O.O92 O.O92
Methyl salicylate O O O.O6 O O.O6 O.O6 O.O6 O.O6 O.O6
Benzyl alcohol O.6 O6 1.O 1.O 1.O 1.O 1.O 1.O 1.O
Grapefruit 2.0 2.0 O O O O
seed extract
1.3 propranediol O.6 O6 O O O O
Lactic acid O.2 O.2 O O.2 O.2 O.2 O.2 O.2 O.2
Sorbital solution O O O.1 O.1 O.1 O.1 O.1 O.1 O.1
Benzoic acid O O O.1 O.1 O.1 O.1 O.1 O.1 O.1
Sodium benzoate O O O.OS O.OS O.OS O.OS O.OS O.OS O.OS
Ethanol 15 15 21.6 21.6 21.6 21.6 21.6 11.104 11.104
Benzalkonium O.1 O O O O O
chloride
Chlorhexidine O 0.1 O O O O
gluconate
Silver nitrate O O O O O.O2 O
Hydrogen peroxide O O O O O.O2 O
Sodium perborate O O O O O O.2
Chlorphyllin O.OO)4 O
Coloring agent O O.OO2 O.OO2
Citrus extract O.S O.S
Triclosan O.15

0141 Table 37 provides a general formulation of compo

sitions for stock Solutions to be used in cream products. TABLE 37-continued

TABLE 37 Composition in Stock Use level in cream (1-1.5%)

Range Range
Composition in Stock Use level in cream (1-1.5%) 1.3 Propanediol 15-40 O.15-0.6
Range Range Tetrhydrocurcuminoid 3-10 O.O3-0.15
Benzyl alcohol 40-85 0.4-1.3
Lactic acid 10-20 O.1-0.3 0142 Table 38 provides the formulations for various pre
servative compositions (PC) of the present invention.

TABLE 38

PC8 PC14 PC18

Cream Cream Cream Cream Cream

Ingredients Stock (1.1% stock) Stock (1.3% stock) Stock (1.2% stock) Stock (1.5% stock) Stock (1.5% stock)
Benzyl alcohol 72.7 O.8 61.5 O.8 834 1.O 66.7 66.7 1.O
1.3 Propanediol 22.7 O.25 19.2 O.25 16.6 O.25 2O.O O.3
Tetrhydro- 4.6 O.OS 3.9 O.OS 3.40 O.OS
curcuminoid
Lactic acid 15.4 O.2 36.6 O.2 13.3 13.3 O.2
US 2012/020 1902 A1 Aug. 9, 2012
20

0143. The compositions of the invention may also be used alcohol and citrus extract. The following Table provides a
for preoperative skin disinfectant compositions. These com nonlimiting Example of Such a composition.
positions contain synergistic combinations of benzyl alcohol,
fruit acid, and antimicrobials such as chlorhexidine glucon TABLE 43A
ate (CHG) or povidone iodine (PVI). The following Table
provides nonlimiting examples of such compositions. Amount in cream
Ingredients Stock (%) containing 1.3% stock
TABLE 39 Benzyl alcohol 61.54 O.8
Citrus extract (BS440D) 15.38 O.2
Pre-Op Pre-Op Pre-Op Pre-Op Tetrahydrocurcuminoid 3.85 O.OS
Disinfectant- Disinfectant- Disinfectant- Disinfectant (THC)
CHG CHG-Gel PVI PVI-Ge. 1,3-propanediol 19.23 O.25
Ingredient % Wiw % ww % Wiw % Wiw
Use level is 1.0-2.0%
Benzyl alcohol 3 3 3 3
Lactic acid 2 2 2 2
SDA3C alcohol 67.2 67.2
CHG 2 2 TABLE 43B
Polyduaternium O.2 O.2
10 Ingredients Composition in Stock (%) Use level
Hydroxypropyl O.2 O.2
methyl cellulose Benzyl alcohol 30-90 O.3-SO
(K4M) Fruit Acid 5-70 0.1-4.0
1.3 propanediol 2 2 1,3-propanediol O-SO O-S.O
Glycerine 4 4 Botanical Extract O-2O O-30
PVI 7.5 7.5 Solvents S-90 O.2-12
Water 25.8 25.4 81.5 81.1
Use level is 1.0-10.0%

0144. The following Table provides nonlimiting examples 0147 Additional neutraceutical preservative (NP) and
of concentrations of preservative compositions in Stock Solu food disinfectant cleanser (FDC) compositions are provided
tions and their use in cream products. below. Specifically, these formulations contain benzyl alco
hol and citrus extract.
TABLE 40
TABLE 44A
Preservative Composition 21A
NP-A Stock (%)
Composition of Cream containing
Ingredients stock solution 1.0% stock Benzyl alcohol 8O
Citirus extract 2O
Benzyl alcohol 8O O.8
Citrus extract 2O O.2
NP-B Stock (%)
Benzyl alcohol 8O
Citrus extract 10
TABLE 41 Grapefruit seed extract 10
Preservative Composition 21B Use Level is 1-2%

Composition of Cream containing TABLE 4.4B

Ingredients stock solution 1.2% stock
Benzyl alcohol 66.7 O.8 FDC % Wiw
Citrus extract 16.7 O.2
Grapefruit seed extract 16.7 O.2 Benzyl alcohol O.S.-S.O
Citric acid O.2-2.O
Citrus extract 0.2-1.0
Grapefruit seed extract O-1.O
0145 The present invention also provides for nutraceuti Natural surfactant O.2-5.O
cal and food antibacterial (NFA) compositions. The follow Water 90-98
ing table provides the a nonlimitig example of an NFA pre pH 3-4
Use undiluted
servative composition. The use level is in 50-200 fold dilution
of stock in water.
TABLE 44C
TABLE 42
FDC-1 % Wiw
Composition of stock Concetration
Ingredients solution level range in use Benzyl alcohol 2.0
Citric acid 1.O
Benzyl alcohol 8O 0.4-1.6 Citrus extract O.2
Citrus extract 1O.O O.OS-O2 Glucopon 215 UP 2.0
Grapefruit seed extract 1O.O O.OS-O2 Water 94.8
pH 3.5
Use undiluted
0146 Additionally, the present invention contemplates
coSmaceutical preservative compositions containing benzyl
US 2012/020 1902 A1 Aug. 9, 2012
21

0148. The present invention also provides for oral care gelling agent such as Stearyl alcohol, cationic hydroxyethyl
compositions. The following Table provides a nonlimiting cellulose (Ucare; JR30), hydroxy propyl methyl cellulose,
example of an oral care composition. hydroxy propyl cellulose (Klucel), chitosan pyrrolidone car
boxylate (Kytamer), behenyl alcohol, Zinc Stearate, emulsi
TABLE 45 fying waxes, including but not limited to Ineroquat and Pola
Ingredients OCP8% (w/w) wax, an addition polymer of acrylic acid, a resin Such as
Carbopol(R) ETDTM 2020, guar gum, acacia, acrylates/ste
Water
Glycerin
76.739
1O.O
areth-20 methacrylate copolymer, agar, algin, alginic acid,
Sodium saccharin O.08 ammonium acrylate co-polymers, ammonium alginate,
Pluronic F127 O.3 ammonium chloride, ammonium sulfate, amylopectin, atta
Zinc salicylate O.OS pulgite, bentonite, C9-15 alcohols, calcium acetate, calcium
Copper salicylate O.O2S
Thymol O.064 alginate, calcium carrageenan, calcium chloride, caprylic
Menthol O.04 alcohol, carbomer 910, carbomer 934, carbomer 934P car
Eucalyptol O.092 bomer 940, carbomer 941, carboxymethylhydroxyethyl cel
Methyl salicylate O.O6 lulose, carboxymethylhydroxypropyl guar, carrageenan, cel
Benzyl alcohol 1.O
Lactic acid O.2 lulose, cellulose gum, cetearyl alcohol, cetyl alcohol, corn
Sorbitol solution O.1 starch, damar, dextrin, dibenzlidine sorbitol, ethylene dihy
Benzoic acid O.1 drogenated tallowamide, ethylene diolamide, ethylene dis
Sodium benzoate
Ethanol
O.OS
10.6
tearamide, gelatin, guar gum, guar hydroxypropyltrimonium
Citrus extract C-320C O.S chloride, hectorite, hyaluronic acid, hydrated silica, hydroxy
butyl methylcellulose, hydroxyethylcellulose, hydroxyethyl
ethylcellulose, hydroxyethyl stearamide-MIPA, isocetyl
014.9 The present invention also provides for aqueous alcohol, isostearyl alcohol, karayagum, kelp, lauryl alcohol,
hand sanitizers containing benzyl alcohol and botanicals. The locust bean gum, magnesium aluminium silicate, magnesium
following table provides three nonlimiting examples of for silicate, magnesium trisilicate, methoxy PEG-22/dodecyl
mulations. glycol copolymer, methylcellulose, microcrystalline cellu
lose, montmorillonite, myristyl alcohol, oat flour, oleyl alco
TABLE 46 hol, palm kernel alcohol, pectin, PEG-2M, PEG-5M. poly
Phase A 18LA8 37D 32
acrylic acid, polyvinyl alcohol, potassium alginate,
potassium aluminium polyacrylate, potassium carrageenan,
Grapefruit seed 1.O O O potassium chloride, potassium Sulfate, potato starch, propy
extract
Citrus extract O O.S O
lene glycol alginate, sodium acrylate/vinyl alcohol copoly
(Biosecure F44OD) mer, sodium carboxymethyl dextran, Sodium carrageenan,
Benzethonium O O O.2 Sodium cellulose Sulfate, sodium chloride, Sodium poly
chloride methacylate, sodium silicoaluminate, Sodium sulfate, Stear
Benzyl alcohol 2 2 2 alkonium bentotnite, Stearalkonium hectorite, Stearyl alco
1.3 Propanediol 3 3 3
Lactic acid 2.0 2.0 O hol, tallow alcohol, TEA-hydrochloride, tragacanth gum,
Citric acid O O 2.0 tridecyl alcohol, tromethamine magnesium aluminium sili
Glucopon 215UP 1 1 1 cate, wheat flour, wheat starch, Xanthan gum, abietyl alcohol,
SDA3C 10 10 O acrylinoleic acid, aluminum behenate, aluminum caprylate,
SDA 4OB O O 10
Phase B aluminum dilinoleate, aluminum salts, such as distearate, and
Water 80.1 80.6 80.8 aluminum isostearates, beeswax, behenamide, butadiene/
HPMC (K4M) O.2 O.2 O.2 acrylonitrile copolymer, C29-70 acid, calcium behenate, cal
Polyguaternium10 O.2 O.2 O.2 cium Stearate, candelilla wax, carnauba, ceresin, cholesterol,
1.3 Propanediol O.S O.S O.S
Zinc lactate O O O.1 cholesterol hydroxy Stearate, coconut alcohol, copal, diglyc
pH 3.3-3.6 eryl Stearate malate, dihydroabietyl alcohol, dimethyl lau
ramine oleate, dodecanoic acid/cetearyl alcohol/glycol
copolymer, erucamide, ethylcellulose, glyceryl triacetyl
4.12 Wound Healing hydroxyStearate, glyceryl tri-acetyl ricinolate, glycol dibe
henate, glycol di-octanoate, glycol distearate, hexanediol dis
0150. The compositions of the present invention may be tearate, hydrogenated C6-14 olefin polymers, hydrogenated
used to treat wound healing or Surface infections. In various castor oil, hydrogenated cottonseed oil, hydrogenated lard,
non-limiting embodiments, the present invention may be uti hydrogenated menhaden oil, hydrogenated palm kernel glyc
lized in products Such as topical creams and lotions, wound erides, hydrogenated palm kernel oil, hydrogenated palm oil,
care products, burn wound cream, decubitous ulcer cream hydrogenated polyisobutene, hydrogenated Soybean oil,
(with anti-inflammatory botanicals and the use of silver sul hydrogenated tallow amide, hydrogenated tallow glyceride,
fadiaZene as an anti-microbial agent), and therapeutic oint hydrogenated vegetable glyceride, hydrogenated vegetable
ments. The present invention may also be applied to wound oil, Japan wax, jojoba wax, lanolin alcohol, shea butter, lau
care items, such as, but not limited to, wound healing oint ramide, methyl dehydroabietate, methyl hydrogenated rosi
ments, wound coverings, burn wound cream, bandages, tape, nate, methyl rosinate, methylstyrene? vinyltoluene copoly
and steri-Strips, and medical articles such as medical gowns, mer, microcrystalline wax, montan acid wax, montan wax,
caps, face masks, and shoe-covers, Surgical drops, etc. myristyleicosanol, myristyloctadecanol, octadecene/maleic
0151. In various non-limiting embodiments of the inven anhyrdine copolymer, octyldodecyl Stearoyl Stearate, oleam
tion, the products may further comprise a thickening and/or ide, oleoStearine, ouricury wax, oxidized polyethylene, oZo
US 2012/020 1902 A1 Aug. 9, 2012
22

kerite, paraffin, pentaerythrityl hydrogenated rosinate, pen acids and polycarboxylic acids (e.g., hydrochloric acid, nitric
taerythrity1 tetraoctanoate, pentaerythrityl rosinate, acid, phosphoric acid, Sulfuric acid, citric acid, glycolic acid,
pentaerythrity1 tetraabietate, pentaerythrityl tetrabehenate, and lactic acid); Vitamins such as vitamin A, vitamin E and
pentaerythrity1 tetraoleate, pentaerythrityl tetrastearate, oph Vitamin C; polyamino acids and salts, such as ethylenedi
thalmic anhydride/glycerin/glycidyl decanoate copolymer, amine tetraacidic acid (EDTA), preservatives such as Germall
ophthalmic/trimellitic/glycols copolymer, polybutene, poly plus and DMDM hydantoin, and Sunscreens such as ami
butylene terephthalate, polydipentene, polyethylene, poly nobenzoic acid, arobenzone, cinoxate, dioxybenzone,
isobutene, polyisoprene, polyvinylbutyral, polyvinyl laurate, homosalate, menthyl anthranilate, octocrylene, octyl meth
propylene glycol dicaprylate, propylene glycol dicocoate, oxycinnamate, octyl salicylate, oxybenzoate, padimate 0,
propylene glycol diisononanoate, propylene glycol dilaurate, phenylbenzimidazole, Sulfonic acid, Sulisobenzone, titanium
propylene glycol dipelargonate, propylene glycol distearate, dioxide, and trolamine salicylate.
propylene glycol diundecanoate, PVP/eiconsene copolymer, 0156. In specific non-limiting embodiments, the present
PVP/hexadecene copolymer, rice bran wax, stearlkonium invention provides for a wound healing topical cream con
bentonite, Stearalkonium hectorite, Stearamide, Stearamide taining silver Sulfadiazine, an insoluble Zinc salt, a soluble
DEA-distearate, stearamide DIBA-stearate, stearamide Zinc salt and calendula oil. In another non-limiting embodi
MEA-stearate, Stearone, Stearyl erucamide, Stearyl Stearate, ment, the present invention provides for a wound healing
Stearyl Stearoyl Stearate, synthetic beeswax, synthetic wax, topical cream containing silver Sulfadiazine, an insoluble Zinc
trihydroxy Stearin, trisononanoin, triisoStearin, tri-isostearyl salt, a soluble Zinc salt, calendula oil, and anti inflammatory
trilinoleate, trilaurin, trilinoleic acid, trilinolein, trimyristin, agents such as a curcumin compound.
triolein, tripalmitin, tristearin, Zinc laurate, Zinc myristate, 0157. The present invention also provides for a topical
Zinc neodecanoate, Zinc rosinate, and mixtures thereof. The antimicrobial, wound healing, anti-inflammatory cream con
gelling agents used in vehicles may be natural gelling agents taining silver Sulfadiazine, an insoluble Zinc salt, a soluble
Such as natural gums, starches, pectins, agar and gelatin. Zinc salt, calendula oil, and synergistic combinations of cur
Often, the gelling agents are based on polysaccharides or cumin compounds, benzyl alcohol, and 1.3 propanediol or
proteins Examples include but are not limited to guar gum, octanediol or decanediol, which also enhance the antifungal
Xanthum gum, Alginic acid (E400), Sodium alginate (E401), activity.
potassium alginate (E402), ammonium alginate (E403), cal 0158. In various embodiments, the compositions further
cium alginate (E404, polysaccharides from brown algae), contain a silver releasing agent. In other embodiments, the
Agar (E.406, a polysaccharide obtained from red seaweeds), compositions further contain a stabilizer.
Carrageenan (E407, a polysaccharide obtained from red sea 0159. Non-limiting examples of cream products may fur
weeds), Locustbean gum (E410, a natural gum from the seeds ther contain white petrolatum (2-20%), fatty alcohol
of the Carob tree), Pectin (E440, a polysaccharide obtained (2-20%), emollient (1-10%), emulsifying agent (0.5-10%),
from apple or citrus-fruit), and Gelatin (E441, made by partial humectant (2-15%), preservative (0.1-0.5%), and deionized
hydrolysis of animal collagen). or distilled water q.s 100%. Fatty alcohols include stearyl,
0152 Various embodiments may comprise a stabilizer. In alcohol, cetyl alcohol, lauryl alcohol, myristyl alcohol, and
a non-limiting example, sodium perborate is used as the sta other known fatty alcohols. Emollients include isopropyl
bilizing agent in an amount ranging from about 0.3 to about myristate, lanolin, lanolin derivatives, isopropyl palmitate,
1% w/w. isopropyl Stearate and other known emollients. Emulsifying
0153 Various embodiments of the invention may further agents include Sodium mono-oleate and polyoxyl 40 Stearate.
comprise a Surfactant. The Surfactant may be an anionic Sur Humectants include propylene glycol, Sorbitol, or glycerine
factant, a cationic Surfactant, an ampholytic Surfactant, or a or mixture thereof. Suitable water soluble preservatives
nonionic Surfactant. Examples of nonionic Surfactants include parabens, Sorbic acid, benzoic acid, diazolidinyl urea,
include polyethoxylates, fatty alcohols (e.g., ceteth-20 (a and iodopropylbutylcarbamate (Germal+).
cetyl ether of polyethylene oxide having an average of about 0160 The following Table provides a general nonlimiting
20 ethylene oxide units) and other “BRIJ”(R) nonionic surfac formulation range of ingredients for topical wound healing
tants available from ICI Americas, Inc. (Wilmington, Del.)). compositions containing silver Sulfadiazine, Zinc salts, ben
cocamidopropyl betaine, alkyl phenols, fatty acid esters of Zyl alcohol and botanicals.
sorbitol, sorbitan, or polyoxyethylene sorbitan. Suitable
anionic Surfactants include ammonium lauryl Sulfate and lau TABLE 47
ryl ether sulfosuccinate. Preferred surfactants include lauroyl % Range of ingredients
ethylenediamine triacetic acid sodium salt, Pluronic F87,
Masil SF-19 (BASF) and incromide. Ingredients % (w.fw)
0154 Water used in the formulations described herein is Petrolatum 8-12
preferably deionized water having a neutral pH. Stearyl alcohol 10-18
0155 Various embodiments of the invention may com Isopropyl myristate
Sorbitan oleate
3-7
1.5-3.5
prise additional additives, including but not limited to a sili Polyoxy 40 stearate (Myri 52) 4.0–7.0
cone fluid (such as dimethicone or cyclomethicone), a sili Mineral oil O-2O
cone emulsion, dyes, fragrances, pH adjusters, including Germal + O. 1-0.3
basic pH adjusters such as ammonia, mono-, di- and tri-alkyl Propylene glycol 1-7
amines, mono-, di- and tri-alkanolamines, alkali metal and Zinc lactate O. 1-0.5
Zinc oxide O. 1-0.5
alkaline earth metal hydroxides (e.g., ammonia, Sodium Calendula oil O.5-2.O
hydroxide, potassium hydroxide, lithium hydroxide, mono Silver sulfadiazine O.5-2.O
ethanolamine, triethylamine, isopropylamine, diethanola Benzyl alcohol O.S.-3.0
mine and triethanolamine); acid pH adjusters such as mineral
US 2012/020 1902 A1 Aug. 9, 2012

botanicals and antifungal agents such as miconazole. Various

TABLE 47-continued topical antifungal agents may be used in the present inven
% Range of ingredients tion, including but not limited to miconazole, oxiconazole,
Sulconazole, clotrimazole, econazole, ketoconozole, Serta
Ingredients % (w.fw) conozol, fluconozole, and amphotericin B. The following
THC O.-0.1
tables provide for general and specific nonlimiting formula
1.3 propanediol(Zemea) O.S.-3.0 tions.
Lactic acid O.01-02
Benzoic acid O. 1-0.5 TABLE 50
Sodium Benzoate O. 1-0.5
Water 40-60 Ingredients % w/w (Range)
pH ranges from about 5 to about 6.8. Water O-70
Polyguartenium10 O-O.3
A specific non-limiting formulation for a topical wound heal Incroquat Behenyl TMS O-4.0
ing composition is provided in the Table below. Polawax O-4.0
Petroleum Jelly 5-65
Stearyl alcohol S-20
TABLE 48 Myri 52 1-7.O
Calendula oil O.-1.0
Specific formulation 1 Silicone fluid 2-10
Propylene Glycol O-S.O
Topical cream ingredients % (w.fw) Isopropyl Myristate 2-.8.0
Sorbitan Oleate O.5-4.O
Petrolatum 10.7 Dipropyleneglycol O-2.O
Stearyl alcohol 16.0 Benzyl alcohol O.S.-S.O
Isopropyl myristate 6.0 Alkanediol O.S.-S.O
Sorbitan oleate 2.7 Tetrahydrocurcuminoid O.05-02
Polyoxy 40 stearate (Myri 52) 6.7 Zinc gluconate 0.1-1.0
Germal + O.3 Zinc Oxide O.5-10
Propylene glycol 2.O Zinc stearate O.S.-S.O
Zinc lactate O.2 Lactic acid O.2-2.O
Zinc oxide O.3 Benzalkonium chloride O-O.2
Calendula oil 1.O Chlorhexidine gluconate 0.2-1.0
Silver sulfadiazine 1.O Topical antifungal agents O.S.-S.O
Benzyl alcohol 2.O
THC O.O2S
1.3 propanediol 2.O
Lactic acid O.O15
Benzoic acid O.2 TABLE 51
Sodium Benzoate O.2
Water 48.06 Specific formulation for antifungal diaper rash ointment
pH is at 6.3. Topical cream ingredients % (w.fw)
Petrolatum 59.05.
Provided below is another nonlimiting example of a topical Stearyl alcohol 12.0
wound healing composition. Isopropyl myristate 4.0
Sorbitan oleate 2.5
TABLE 49 Polyoxy 40 stearate (Myri 52) 6.O
Calendula oil O.8
Zinc stearate 3.0
Specific formulation. 2 Zinc gluconate 0.4
Zinc oxide 7.0
Topical cream ingredients % (w.fw) Miconazole 2.0
Petrolatum 10.7 Lactic acid 1.O
Stearyl alcohol 16.0 Benzyl alcohol 1.O
Isopropyl myristate 6.0 THC O.OS
Sorbitan oleate 2.7 1.3 propanediol( Zemea) 1.O
Polyoxy 40 stearate (Myri 52) 6.7 Chlorhexidine gluconate O.2
Germal + O.3
Propylene glycol 2.O
Zinc lactate O.2
Zinc oxide O.3 4.13 Veterinary Products
Calendula oil 1.O
Silver sulfadiazine 1.O
Benzyl alcohol O.S 0162. In a subset of non-limiting embodiments, the
THC O. present invention provides for veterinary products for care of
1.3 propanediol 2.O any domestic animal, including but not limited to cats, dogs,
Lactic acid O.O15
Benzoic acid O.2 birds, rodents, rabbits, horses, cows and cattle, sheep, goats,
Sodium Benzoate O.2 etc.
Water SO.185 0163 Non-limiting examples of veterinary care products
pH is at 6.0. which may utilize the invention include pet shampoo, pet
cleansing wipes including body wipes, ear wipes, and eye
0161 The present invention also provides for antifungal wipes, dental wipes, toothpaste, ear cleaning liquid, cage
diaper rash creams and ointments containing benzyl alcohol, cleaner, Surface cleaner for housebreaking accidents, topical
US 2012/020 1902 A1 Aug. 9, 2012
24

creams, ointments, teat dip therapeutic for mastitis and liquid

to be applied to pet's skin (as in a “body splash'). TABLE 54
0164 Veterinary care compositions according to the Mastitits treatment lotion 2 % (w.fw)
invention may further comprise one or (preferably) more than Safflower oil 17.0
one component selected from the group consisting of emol Water 66.9
lients, stabilizing agents, thickening agents, humectants, anti Xanthum gum O45
microbial agents, neutralizing agents, Surfactants, water, sili Hydroxycurcuminoid O.15
Benzyl alcohol 1.O
cone polymers, alcohols, and hydrogels, anti-inflammatory Symrelief (Bisabolol + Ginger extract) O.2
agents, wound healing agents, salicylic acid, as well as addi Calendula oil O.S
Glycerin 10.6
tional components as may be known in the art. Grape fruit seed extract 3.0
0.165 Specific, non-limiting examples of additional com Lactic acid O.2
ponents which may be comprised in pet care products include pH adjusted with 10N NaoH 6.5-6.7
the components listed above for personal care products.
0166 In certain non-limiting embodiments of the inven
tion, the compositions may be prepared for teat dip to treat TABLE 55
mastitis. A general formulation for teat dip compositions is as Mastitits treatment lotion 3 % (w.fw)
follows.
Safflower oil 17.0
Water 61.54
TABLE 52 Xanthum gum O.45
Hydroxycurcuminoid O.15
General Formulation Benzyl alcohol 1.O
Ingredients % (w.fw) Pomegranate seed oil O.1
Calendula oil O.S
Safflower oil 10-20 Glycerin 10.6
Lemongrass oil O-O.3 Grape fruit seed extract 3.0
Water 50-70 Lactic acid O.2
Xanthum gum O-O.S pH adjusted with 10N NaoH 6.5-6.7
Zinc lactate O-O.2
Symrelief (Bisabolol + Ginger extract) 0-0.2
Curcumin O-O.2
PSO O-O.2 TABLE 56
Benzyl alcohol O-S.O
1.3 propanediol O-S.O Mastitits treatment lotion 4 % (w.fw)
Calendula oil O.5-0.1
Glycerin S-12 Safflower oil 17.0
Grape fruit seed extract O.2-3.0 Water 68.0
Lactic acid O2- 0.5 Xanthum gum O45
pH adjusted with 10N NaoH 6.5-6.7 Hydroxycurcuminoid O.15
Benzyl alcohol 1.O
Zemea (R) 1.O
Pomegranate see oil O.1
0167. The anti-irritants used for teat dip may include but Calendula oil O.S
are not limited to Zinc salts with panthenol, or Bisabolol with Glycerin 10.6
ginger root extract (symrelief), or symrelief with a Zinc salt. Grape fruit seed extract 1.O
Lactic acid O.2
The gelling agents in the vehicle may include but are not pH adjusted with 10N NaoH 6.5-6.7
limited to natural gelling agents such as natural gums,
starches, pectins, agar and gelatin. Antimicrobial botanicals
may include but are not limited to lemongrass oil, orange oil TABLE 57
and fruit acids such as citric and lactic acid, phenoxyethanol
(constituent of Sage oil). The following Tables Summarize Cow teat dip Solution ingredients % (w.fw)
various non limiting examples of formulations. Safflower oil 1O.O
Water 74.1
TABLE 53 Xanthum gum O.45
Hydroxycurcuminoid O.15
Mastitits treatment lotion 1 % (w.fw) Benzyl alcohol 1.O
Zemea (R) 1.O
Safflower oil 17.0 PCL liquid 100 (Symrise) 1.O
Lemongrass oil O.1 Calendula oil O.S
Water 67.75 Glycerin 10.6
Xanthum gum O45 Grape fruit seed extract 1.O
Zinc lactate O.2 Lactic acid O.2
Symrelief (Bisabolol + Ginger extract) O.2 pH adjusted with 10N NaoH 6.5-6.7
Calendula oil O.S
Glycerin 10.6
Grape fruit seed extract 3.0 4.14 Household/Industrial Products
Lactic acid O.2
pH adjusted with 10N NaoH 6.5-6.7 0.168. In a subset of non-limiting embodiments, the
present invention provides for household/industrial products
comprising the formulations outlined above.
US 2012/020 1902 A1 Aug. 9, 2012

0169. Non-limiting embodiments of household/industrial 0178. In various non-limiting embodiments of the inven
products which may utilize the invention include householder tion, the compositions used in a household/industrial product
cleaners such as concentrated liquid cleaners and spray clean may further comprise a bleaching agent, for example, but not
ers, cleaning wipes, dish washing liquid, dish washer deter limited to, sodium hypochlorite, hydrogen peroxide, sodium
gent, spray-mop liquid, furniture polish, indoor paint, out percarbonate and Sodium perborate.
door paint, dusting spray, laundry detergent, fabric Softener, 0179. In various non-limiting embodiments of the inven
rug/fabric cleaner, window and glass cleaner, toilet bowl tion, the compositions used in a household/industrial product
cleaner, liquid/cream cleanser, etc. In a particular embodi may further comprise an enzyme, such as, but not limited to,
ment, the invention may be used in a food wash product, a protease or a lipase.
designed to clean fruits and vegetables prior to consumption. 0180. In various non-limiting embodiments of the inven
“Household products are products, other than personal care tion, the compositions used in a household/industrial product
products, that would be used by individual consumers. may further comprise a preservative, such as, but not limited
“Industrial products” refers to products that are used in indus to, butylated hydroxytoluene, glutaraldehyde, and EDTA.
try. 0181. In various non-limiting embodiments of the inven
0170 Household-industrial compositions according to the tion, the compositions used in a household/industrial product
invention may further comprise one or (preferably) more than may further comprise a Sudsing agent, such as, but not limited
one component selected from the group consisting of Surfac to, diethanolamine or triethanolamine.
tants, builders (e.g., sequestering builders, precipitating 0182. In specific, non-limiting embodiments, the present
builders, ion exchange builders), Solvents, thickeners, abra invention provides for the following Surface cleaners, having
sives, acids, bases (alkalis), antimicrobial agents, Soaps, concentrations of active ingredients as well as concentrated
bleaching agents, enzymes, preservatives, and Sudsing stock solutions of these formulations which may be diluted to
agents, as well as additional components as may be known in achieve the respective concentrations.
the art. 0183 The following Table 58A provides a general formu
0171 In various non-limiting embodiments of the inven lation for Surface disinfectants composition containing ben
tion, the compositions may further comprise a surfactant, for Zyl alcohol, fruit acid and biguanide.
example, but not limited to, an anionic Surfactant such as an
alkyl Sulfate, an alkyldiphenyloxide disulfonate Salt (e.g., the TABLE 58A
DOWFAX series by the Dow Chemical Company), an alky
lbenzenesulfonate, an alcohol ethoxysulfate; a cationic Sur Ingredient % Wiw
factant; a non-ionic Surfactant, such as a secondary alcohol Vantocil O. 1-0.5
ethoxylate (e.g., the TERGITAOL series by the Dow Chemi Glucopon (alkylpolyglycoside) O.S.-3.0
cal Company) or an alkyl polyglucoside (e.g., the TRITON Lactic acid O.2-2.O
series by the Dow Chemical Company); or an amphoteric Citric acid
Benzoic acid
O-2O
O-1.O
Surfactant Such as an imidazoline or betaine compound. Benzyl alcohol O.5-1O.O
0172. In various non-limiting embodiments of the inven Aliphatic Alcohol O-10
tion, the compositions may further comprise a solvent, for Water 80-95
example, but not limited to, water, an alcohol Such as metha
nol, ethanol, isopropyl alcohol, or butanol; a hydrocarbon 0.184 Table 58B provides a general formulation for stock
Such as an aromatic hydrocarbon, propylene glycol, methyl Surface cleanser.
ene chloride, acetone, a petroleum distillate, and/or a glycol
ether.
TABLE 58B
0173. In various non-limiting embodiments of the inven
tion, the compositions used in a household/industrial product Ingredients % w/w (Range)
may further comprise a thickener, for example, but not limited Chlorhexidine gluconate O.OO-2.OO
to, a polyethylene glycol. a methoxypolyethylene glycol, Polyhexamethylene Biguanide 1.OO-6.OO
and/or hydroxyethyl cellulose. Benzethonium chloride S.OO-12.OO
0.174. In various non-limiting embodiments of the inven Triclosan O.OO-1O.OO
tion, the compositions used in a household/industrial product Incroquat Compounds O.10-100
Diglycerol O.OO-S.OO
may further comprise an abrasive. Such as, but not limited to, Dipropylene glycol OSO-5.00
silica, feldspar or calcite. Non ionic Pluronic L64 OSO-2.OO
0.175. In various non-limiting embodiments of the inven Non ionic Pluronic RA30
Non ionic Pluronic 25 R4
O.25-1.OO
O.25-1.OO
tion, the compositions used in a household/industrial product SDA 40B alcohol 1O.OO-2O.OO
may further comprise an acid, such as, but not limited to, Water 40.OO-90.OO
acetic acid, hydroacetic acid, phosphoric acid or hydrochloric Octanediol S.OO-12.OO
acid. Salicylic acid O.OO
Salts of salicylic acid O.OO
0176). In various non-limiting embodiments of the inven Essential oils O.OO
tion, the compositions used in a household/industrial product Botanicals O.OO
may further comprise a base (alkali) Such as, but not limited Benzyl alcohol O.OO
to, ammonia or sodium bicarbonate. Long Chain Quaternary ammonium 1.OO-5.00%
Compounds
0177. In various non-limiting embodiments of the inven
tion, the compositions used in a household/industrial product
may further comprise an antimicrobial agent, for example, The level of use is diluting 1 to 5 ounces of the stock solution
but not limited to, compounds as set forth above for personal to 1 gallon of water. Table 58C provides an alternative for
care compositions, and also pine oil and sodium hypochlorite. mulation for Stock Surface cleansers.
US 2012/020 1902 A1 Aug. 9, 2012
26

0191 The following preservative compositions were pre

TABLE 58C pared, adjusted the pH to 5.0 and added to a hydrophilic
Ingredients % w/w (Range)
cream base and tested for their efficacy against Aspergillus
niger (Fungus) and C. albicans, which are the most prevalent
Polyhexamethylene Biguanide
Benzethonium chloride
1.OO-6.OO
S.OO-12.OO
contaminant in creams and is difficult to eradicate. The spe
Incroquat compounds O.10-0.50 cific method used is described in Example 6. The pH of all the
Diglycerol O.OO-S.OO preservatives were adjusted between 4.5-5.0. 1-2% of the
Dipropylene glycol O.OO-S.OO preservatives were used.
Non ionic Surface cleaner S-30.O
SDA 40B alcohol 1O.OO-2O.OO
Water 40.OO-90.OO TABLE 59
Alkanediol S-12.OO
Salicylic acid O.OO Efficacy (logio
reduction from
Salts of salicylic acid O.OO
Essential oils O.OO % w/w in % wiw in control growth)
Botanicals O.OO Preservative Ingredient stock Ce3 A. niger
Fruit acids 10-50 Preservative 1 GSE 100 O.2 1.2
Benzyl alcohol 10-50 Preservative 2 Benzyl alcohol 100 O.S O.98
(natural)
Preservative 3 GSE 28.6 O.2 3.1
4.15 Medical Devices Benzyl alcohol 71.4 O.S
Preservative 4 Benzyl alcohol 50 O.S 1.O
0185. In a subset of non-limiting embodiments, the Natural 1.3 50 O.S
present invention provides for medical devices comprising propanediol
the formulations outlined above. (Zemea (R)
0186 Implantation of a medical device produces rapid Preservative 5 Benzyl alcohol
Zemea (R)
41.7
41.7
O.S
O.S
3.9
inflammatory reaction at the implantation site. This may GSE 16.6 O.2
result in the formation of a biofilm on the surface of the
medical device. The biofilm on the surface of a medical *Control growth - 1 x 10-5 x 10'
device serves as a receptor for microbes resulting in microbial
adhesion. Prevention of inflammation around the implanted 0.192 Conclusion: GSE and benzyl alcohol exhibits syn
medical device can prevent bacterial adherence on the device. ergistic efficacy. 1.3 propanediol renders the solution clear
This may be achieved by maintaining an inflammation and and enhances the activity. The synergistic activity can also be
infection-free environment around the device by coating and/ seen between benzyl alcohol ZemeaR) mixture and GSE.
or impregnating the device with antiinflammatory agents and
antimicrobials.
0187 Anti-inflammatory antimicrobial compositions Example 2
comprising synergistic combination of benzyl alcohol, 1.3 0193 The present example provides an evaluation of the
propanediol and THC (with or without other antimicrobials synergistic efficacy of benzyl alcohol (synthetic) and GSE
Such as chlorhexidine and silver salts) can be used to coat or and 1.3 propanediol (synthetic).
impregnate medical devices such as catheters, wound dress
ing, Soft tissue patches, etc. TABLE 60
5. EXAMPLES
0188 The detailed description hereby incorporates, by Efficacy (logo
reduction from
reference, the specific working examples of the invention set % w/w in % wiw in control growth)
forth below. Preservative Ingredient stock Ce3 A. niger
0189 The working examples sometimes refer to Soft Preservative Benzyl alcohol 41.7 O.S 4.1
soap(R) or DialR) soaps. SoftsoapR is a commercially sold SA (synthetic)
liquid Soap comprising water, sodium laureth Sulfate, coca 1.3 propanediol 41.7 O.S
midopropyl betaine, decylglucoside, sodium chloride, fra (synthetic)
GSE 16.6 O.S
grance, DMDM hydantoin, PEG-120 methyl glucose
dioleate, tetrasodium ethylene diamine tetracetic acid, *Control growth - 1 x 10-5 x 10'
Sodium Sulfate, polyduaternium-7, citric acid, poloxamer
124, PEG-7 glyceryl, cocoate, benzophenine-4, and colors. 0194 Conclusion: Synthetic benzyl alcohol and 1.3 pro
DialR) soap is a commercially sold liquid soap, where DialR) panediol along with GSE show similar efficacy to the formu
Antibacterial hand Soap comprises, as active agent, 0.15 per lation that uses natural components.
cent triclosan, and the inactive agents are water, sodium lau
reth Sulfate, ammonium lauryl Sulfate, decylglucoside, coca Example 3
midopropyl betaine, glycerine, sodium chloride, PEG-18
gylceryl oleate/cocoate, fragrance, cocamide MEA, DMDM 0.195 The present example provides an evaluation of the
hydantoin, tetrasodium ethylene diamine tetracetic acid and synergistic effect of various fragrant and non-fragrant botani
colors.
cals with benzyl alcohol, and ZemeaR).
Example 1 0196. In order to determine whether the synergism seen
0190. The present example provides an evaluation of the between non-fragrant GSE and a benzyl alcohol-ZemeaR)
synergistic efficacy of benzyl alcohol and GSE, with and mixture is unique to GSE or other botanicals also, the follow
without 1.3 propanediol. ing botanicals were tested and the results are given below.
US 2012/020 1902 A1 Aug. 9, 2012
27

0197) The following Table provides a summary of the

efficacy of individual botanicals against A. niger. TABLE 63-continued
TABLE 61
Efficacy (logo
Efficacy (logio reduction from
reduction from % w/w in % wiw in control growth)
% w/w in % wiw in control growth) Preservative Ingredien stock Ce3 A. niger
Fragrant Ingredient stock Ce3 A. niger
Fragrant LGO 1OO O.3 0.73 Preservative 7 Benzyl alcohol 40 O.S
Fragrant BO 1OO O.3 O.87 Lactic acid 2O O.2
Fragrant CO 1OO O.3 O.88 Glycerin 40 O.3 O.S
Non-Fragrant PSO 1OO O.OS O.87 Preservative 8 GSE 2O.O O.3
Non-Fragrant KP 1OO O.3 O.89
Non-Fragrant THC 1OO O.15 O.S8 Benzyl alcohol 33.3 O.S
Glycerin 33.3 O.S
*Control growth - 1 x 10-5 x 10' Lactic acid 13.3 O.2 2.9
Preservative 9 Lactic acid 16.6 O.2
0198 The following table provides a summary of the effi Benzyl alcohol 41.7 O.S
cacy of botanicals in combination with benzyl alcohol-Ze Zemea (R) 41.7 O.S 1.O
meaR) against A. niger. Preservative 10 GSE 17.24 O.25
TABLE 62 Lactic acid 13.79 O.2
1.3 propanediol 68.97 1.O 1.O
Efficacy (logio (Zemea (R)
reduction from Preservative 11 GSE 26.7 0.4
% w/w in % wiw in control growth) Lactic aci 13.3 O.2
Preservative Ingredien stock Ce3 A. niger
Zemea (R) 33.3 O.S
Preservative 4 Benzyl alcoho SO.O O.S Ethyl alcohol 26.7 0.4 1.2
Zemea (R) SO.O O.S 1.O Preservative 12 GSE 2O O.3
Preservative 4X Benzyl alcoho 66.67 1.O Benzyl alcohol 33.3 O.S
Zemea (R) 33.3 O.S 2.2
Preservative 4A LGO 23 O.3 Zemea (R) 33.3 O.S
Benzyl alcoho 38.5 O.S Lactic acid 13.3 O.2 3.9
Zemea (R) 38.5 0.5 3.8
Preservative 4B CO 23.0 O.3 *Control growth - 1 x 10-5 x 10'
Benzyl alcoho 38.5 O.S
Zemea (R) 38.5 O.S 2.54
Fragrant BO 23.0 O.3 0201 Conclusion: No significant activity was seen with
Preservative 4C Benzyl alcoho 38.5 O.S the solution of GSE and lactic acid in combination with either
Zemea (R) 38.5 O.S 1.O Glycerin or ZemeaR) or ZemeaR) and ethyl alcohol. Benzyl
Non-fragrant PSO 4.8 O.OS
Preservative 4D Benzyl alcoho 47.6 O.S alcohol and lactic acid in combination with either Glycerin or
Zemea (R) 47.6 O.S 1.29 Zemea R, also had no significant activity. However, synergis
Non-fragrant KP 23.0 O.3
Preservative 4E Benzyl alcoho 38.5 O.S tic activity was seen between (1) GSE, lactic acid, ZemeaR),
Zemea (R) 38.5 O.S 1.03 and benzyl alcohol; and (2) GSE, lactic acid, glycerin and
Non-fragrant THC 9.1 O.15 benzyl alcohol. Superior synergistic activity was seen with
Preservative 4F Benzyl alcoho 60.6 1.O
Zemea (R) 30.3 O.S 4.2 GSE, lactic acid, ZemeaR) and benzyl alcohol.
*Control growth - 1 x 10-5 x 10'
Example 5
0199 Conclusion: Among the botanicals tested, only
Lemongrass oil, cinnamon oil and THC exhibit synergism 0202 The present example provides an evaluation on the
with the benzyl alcohol-ZemeaR) (BA-Z) combination. effect of the addition of benzyl alcohol to the combination of
GSE, Zemea R, lemongrass oil, and lactic acid.
Example 4
TABLE 64
0200. The present example provides an evaluation of the
effect of fruit acid (lactic acid) on the efficacy of (1) benzyl Efficacy (logo
alcohol, GSE and ZemeaR); and (2) benzyl alcohol, GSE and reduction from
glycerin. Glycerin was used as the solvent for GSE and lactic % w/w in % wiw in control growth)
Preservative Ingredient stock Ce3 A. niger
acid. A. niger was used as the test organism.
Preservative 13 GSE 16.7 O.25
TABLE 63 Lactic acid 13.3 O.2
Zemea (R) 66.7 1.O
Efficacy (logio Lemongrass oil 3.3 O.OS 1.12
reduction from Preservative 14 GSE 16.7 O.25
% w/w in % wiw in control growth) Lactic acid 13.3 O.2
Preservative Ingredient stock Ce3 A. niger Benzyl alcohol 33.3 O.S
Lemongrass oil 3.3 O.OS
Preservative 6 GSE 40 O.3 Zemea (R) 33.3 O.S 4.2
Lactic acid 2O O.2
Glycerin 40 O.S 1.2 *Control growth - 1 x 10-5 x 10'
US 2012/020 1902 A1 Aug. 9, 2012
28

0203 Conclusion: Benzyl alcohol exhibits synergistic Example 7

activity with the combination of GSE, lemongrass oil, and
lactic acid. 0206. The present example demonstrates the efficacy of
the addition of anti-inflammatory and antifungal tetra-hy
Example 6 drocurcuminoids to preservative compositions containing
GSE, lactic acid, benzyl alcohol and ZemeaR).
0204 The present example describes the method of testing 0207 Curcuminoids are yellow in color and may not be
the preservative efficacy of various preservative composi suitable for personal care composition. Therefore, tetrahy
tions. drocurcuminoids, which are color-free compounds derived
0205 Method 1. An overnight culture of bacteria grown in from the yellow curcuminoids, were evaluated. The use of
Trypticase Soy Broth (TSB) was diluted with TSB to obtain anti-inflammatory curcuminoids, along with the natural pre
108 CFU organism/ml (yeast and Fungi i.e. C. albicans and A. servative described in this invention, not only prevents spoil
niger grown in Sabaraud dextrose broth is diluted to obtain age of personal care products by eradicating the microbial
1x107 cfu organism/ml). For the test samples, the preserva contamination, but may also lower irritation and inflamma
tive was added to 10 grams of the cream at 1-1.5% and mixed tion on the skin caused by the ingredients in the products. The
well. From this sample, 1 gram aliquots were placed into 10 following exemplary, but not limiting, list of curcuminoids
ml sterile plastic culture tubes and 0.1 ml (100 micro liters) of can be used in the present invention: tetrahydrocurcumin,
the test inoculum was added and vortexed until uniformly tetrahydrodemethoxy-curcumin, tetrahydrobisdemethoxy
blended. The tubes were then placed into incubators under the curcumin, and mixtures thereof.

TABLE 65
Efficacy (logio Efficacy (logio
reduction from reduction from
% w/w %w/w control growth) control growth)
Preservative Ingredient in stock in cream A. niger C. albicans
Preservative 15 GSE 14.3 O.2
Lactic acid 14.3 O.2
Zemea (R) 35.7 0.5
Benzyl alcohol 35.7 O.6 3.7 4.5
Preservative 16 GSE 13.3 O.2
Lactic acid 13.3 O.2
Zemea (R) 33.3 O.S
Benzyl alcohol 37.3 O.S6
tetrahydrocurcuminoid 2.8 O.04 4.2 7.4
Preservative 17 Lactic acid 16.1 O.2
Zemea (R) 40.3 O.S
Benzyl alcohol 40.3 O.S
tetrahydrocurcuminoid 3.23 O.04 O.96 2.7

*Control growth - 1 x 10-5 x 10' for aspergius and 1 x 10'-5 x 10' for candida in all groups

following temperatures: 30° C. for Aspergillus niger and 37° 0208 Conclusion: Tetrahydro curcuminoids enhances the
C. for the remaining three microbes. All tubes were incubated activity of composition containing GSE, lactic, ZemeaR), and
for a 1 day for bacteria and 2 days for Fungi and yeast. At the benzyl alcohol.
end of the incubation period, 9.0 ml of Butterfield Phosphate Example 8
Buffered solution with neutralizer was added to the incubated
cultured sample and vortexed until completely mixed. The 0209. The present example demonstrates the effect of the
samples were serially diluted and then plated in Trypticase addition of various solvents on a composition containing
soyagar (TSA). The plates were incubated at 37°C. tempera lemongrass oil, GSE, and lactic acid. The solvents used are
ture for 24-48 hours, and the counts were read. Placebo cream (1) Glycerin, (2) Benzyl alcohol, (3) Octoxyglycerin (Sen
was tested similarly and used as the control. Siva), and (4) Zemea R, Octoxyglycerin.

TABLE 66

Efficacy (logio Efficacy (logio

reduction from reduction from
% w/w %w/w control growth') control growth)
Preservative Ingredient in stock in cream A. niger C. albicans

Preservative 18 GSE 13.3 O.2

Lactic acid 13.3 O.2
Zemia 33.3 O.S
Benzyl alcohol 36.7 0.55
Lemongrass oil 3.3 O.OS 4.2 6.5
US 2012/020 1902 A1 Aug. 9, 2012
29

TABLE 66-continued
Efficacy (logio Efficacy (logio
reduction from reduction from
% w/w % wiw control growth) control growth)
Preservative Ingredient in stock in cream A. niger C. albicans
Preservative 19 GSE 11.8 O.2
Lactic acid 11.8 O.2
Zemea (R) 29.4 O.S
Sensiva 44.1 0.75
Lemongrass oil 2.9 O.OS 1.8 6.5
Preservative 19A GSE 11.8 O.2
Lactic acid 11.8 O.2
Zemea (R) 73.5 1.25
Lemongrass oil 2.9 O.OS 1.12 3.84
Preservative 20 GSE 13.3 O.2
Lactic acid 13.3 O.2
Sensiva 70.O 1.OS
Lemongrass oil 3.3 O.OS 1.92 6.5
*Control growth - 1 x 10-5 x 10 for aspergillus and 1 x 10-5 x 10' for candida in all groups

0210 Conclusion: The addition of benzyl alcohol to the

combination of GSE, lemongrass oil and lactic acid exhibits TABLE 67-continued
a higher efficacy against A. niger and C. albicans. Addition of
Sensiva without benzyl alcohol is effective against C. albi Efficacy (logio Efficacy (logio
reduction from reduction from
cans but not against A. niger. Ingredients % w/w in control growth) control growth)
Preservative C8 A. niger C. albicans
Example 9
GSE - THC O2 + 0.15 1.2 1.7
0211 The present examples provides an evaluation of the GSE + THC + Benzyl 0.2 + 0.15 + 4.2 7.5
synergistic efficacy of benzyl alcohol and GSE with higher alcohol + Zemea (R) 1 + 0.5
(0.15%) concentration of tetrahydrocurcuminoids (THC). Benzyl alcohol + THC 1 - 0.15 4.2 6.8
Zemea (R) O.S O.85 O.S

TABLE 67 *Control growth- 1 x 10-5x 10' for aspergius and 1X 10-5x10' for candida in all groups
Efficacy (logio Efficacy (logio
reduction from reduction from 0212 Conclusion: No enhanced efficacy was seen when
Ingredients % ww in control growth) control growth) THC was added to GSE. Higher concentrations of benzyl
Preservative Ce3 A. niger C. albicans alcohol and THC exhibit synergistic activity against both A.
GSE 1.2
niger and C. albicans. Significant synergism is seen against
Benzyl alcohol 1.O s C. albicans. Higher concentrations of benzyl alcohol also
Benzyl alcohol 1.O 1.9 2.7 exhibits synergistic activity with Zemea Ragainst C. albicans
THC O.15 O.S8
Benzyl alcohol + 1 - O.S 2.2 3. Example 10
Zemea (R) 0213. The present example provides the efficacy of PSO to
the preservative containing THC.
TABLE 68
Efficacy (logo Efficacy (logo
reduction from reduction from
Ingredients % w/w %w/w control growth) control growth)
Preservative Preservative in stock in cream A. niger C. albicans
Preservative 22 GSE 2O O.2
Zemea (R) 25 O.S
Benzyl alcohol 50 O.S
tetrahydrocurcuminoids S.O O.OS 4.2 7.5
Preservative 23 GSE 16.7 O.2
Zemea (R) 20.8 O.S
Benzyl alcohol 41.6 O.S
Lactic acid 16.7 O.2
Tetrahydrocurcuminoids 4.2 O.OS 4.2 7.5
Preservative 24 GSE 16.7 O.2
Zemea (R) 20.8 O.S
Benzyl alcohol 41.6 O.S
Lactic acid 16.7 O.2
Pomegranate 4.2 O.OS 4.2 7.5
seed oil (P50)
*Control growth - 1 x 10-5 x 10 for aspergius and 1 x 10-5 x 10' for candida in all groups
US 2012/020 1902 A1 Aug. 9, 2012
30

0214 Conclusion: The addition of pomegranate seed oil

and THC to preservatives containing GSE, ZemeaR), benzyl TABLE 70
alcohol and lactic acid (preservative 15) showed enhanced Efficacy (logio
efficacy against C. albicans. reduction from
Example 11 % Wiw % w/w control growth)
Preservative Ingredient in stock in cream C. Albicans
0215. The present example evaluates the efficacy of vari Fragrant LGO 100 4.8
ous products comprising synergistic combination of benzyl Preservative 25 BO 100 4.8
alcohol, Zemea R, and botanicals. CO 100 4.9
0216) Specifically, fragrance free anti-inflammatory pre- Non-fragrant PSO 100 1.5
servative compositions comprising GSE, benzyl alcohol Preservative 26 PSO 100 1.5
KP 100 1.5
derived from Cassia plant, 1.3 Propanediol (Zemea R, THC 100 1.2
DuPont Tate and Lyle) derived from corn sugar, anti-inflam Preservative 2 Benzyl alcohol 100 1.O
matory agents, and CRMN (particularly white colored tet (natural)
rahydrocurcuminoid) were evaluated. The following preser- Preservative 4 Benzyl alcohol 38.5
Vative compositions were made and tested against bacteria, Zemea (R) 38.5 2.7
fungus and yeast.

TABLE 69

Efficacy (logo reduction

from control growth)
% Wiw % Wiw A. C. S. P
Preservative Ingredient in stock in cream niger albicans atiretts Aeruginosa
Preservative GSE 16.7 O.2
15A Zemea (R) 41.65 O.S
Benzyl alcohol 41.65 0.5
Preservative GSE 14.3 O.2 3.7 4.5 >7 >7
1SB Zemea (R) 35.7 O.S
Benzyl alcohol 35.7 O.S
Lactic acid 14.3 O.2
Preservative GSE 2O O.2 4.6 4.5 >7 >7
22 Zemea (R) 25 O.S
Benzyl alcohol 50 O.S
Tetrahydro S.O O.OS
curcuminoids
Preservative GSE 16.7 O.2 4.6 7.3 >7 >7
23 Zemea (R) 20.8 O.S
Benzyl alcohol 41.6 O.S
Lactic acid 16.7 O.2
Tetrahydro 4.2 O.OS
curcuminoids

*Control growth -1 x 10-5 x 10 in A. niger" and 2x 10-5 x 10' for all other organisms

Example 12
TABLE 70-continued
0217. The present example provides an evaluation of the
synergistic activity of various fragrant and fragrant free Efficacy (logio
botanicals with benzyl alcohol and ZemeaR) against C. albi reduction from
CCS. % w/w control growth)
0218. The following formulations were added to a cream. Preservative Ingredient in stock in cream C. Albicans
The pH was adjusted to 4.5-4.7, and the formulations were
tested for preservative activity using Method 1 as described in Fragrant LGO 23.0
Example 6. Non-fragrant botanicals such as pomegranate Preservative 4A Benzyl alcohol 38.5
Zemea (R) 38.5 7.2
seed oil (PSO), mixtures of edible plant extract Kefiprotect Fragrant CO 23.0
(KP), tetrahydrocurcuminoid (THC), and fragrant botanicals Preservative 4B Benzyl alcohol 38.5
Such as lemongrass oil (LGO), basil oil (BA) and cinnamon Zemea (R) 38.5 7.2
oil (CO) were tested. The botanicals alone were dissolved in Fragrant BO 23.0
2.5% ethanol and used in the cream for testing. The fragrant Preservative 4C Benzyl alcohol 38.5
oil containing preservatives can be used in skin cleansers and Zemea (R) 38.5 7.2
shampoos.
US 2012/020 1902 A1 Aug. 9, 2012
31

Example 14
TABLE 70-continued
0222. The present example provides an evaluation of rapid
Efficacy (logio efficacy (30 second kill) of soaps containing various AM-AI
% w/w
reduction from
% wiw control growth)
compositions against S. aureus.
Preservative Ingredient in stock in cream C. Albicans 0223 Method 2: 8% of each AM-AI formulation is added
Non-fragrant PSO 4.8 O.OS
to 92% of the plain soap (commercial Softsoap(R), mixed and
Preservative 4D Benzyl alcohol 47.6 O.S
pH is adjusted to 3.2-3.3 with NaOH. The soaps were tested
Zemea (R) 47.6 O.S 3.8 for their efficacy as follows. A mixture of 0.1 ml of 108 cfu/ml
Non-fragrant PSO 23.0 O.3 of bacterial culture and 0.1 ml of bovine serum was placed in
Preservative 4D-1 Benzyl alcohol
Zemea (R)
38.5
38.5
O.S
O.S S.6
a sterile culture tube. 0.8 ml of the test soap formulation was
Non-fragrant KP 23.0 O.3 added to the tube and vortexed for 30 seconds. 9.0 ml drug
Preservative 4E Benzyl alcohol 38.5 O.S neutralizing fluid (DNF) was added to the tube to neutralize
Zemea (R) 38.5 O.S 7.2 the activity of the soap, this tube was vortexed and serially
Non-fragrant THC 9.1 O.15 diluted with DNF. 0.5 ml of the diluted solution was plated on
Preservative 4F Benzyl alcohol 60.6 1.O trypticase soyagar plates, incubated at 37°C. for 24-48 hours,
Zemea (R) 30.3 O.S 7.2
and the colony counts were determined. The plain soap with
*Control growth - 1 x 10-5x 10' for aspergius and 1 x 10-5x 10' for candida in all groups out any AM-AI formulation and phosphate buffered saline
(PBS) was also inoculated with culture and processed under
similar conditions.
0219 Conclusion: All of the non-fragrant botanicals (anti
inflammatory agents) except PSO demonstrated Synergism TABLE 73
with the benzyl alcohol and ZemeaR) combination. PSO was
used at very low concentration in this test. Rapid antimicrobial activity (30 second Kill)
(Test Organism S. aureus)
Log10 reduction from control growth
Example 13
Plain soap (control) O.6
AM-AI-7 Soap 7.2
0220. The present example evaluates botanical antimicro AM-AI-16 Soap 7.2
bial and anti-inflammatory (AM-AI) compositions for use in AM-AI-17 Soap 7.2
skin cleansers and topical creams. The following Table pro AM-AI-18 Soap 7.2
vides a general formula for the AM-AI compositions for skin Bacterial growth in Control (PBS) ranges from 1.3-1.7 x 107.
cleanser. From about 8 to about 10% is added to skin cleans
CS.
Example 15
TABLE 71
0224. The present example evaluates the effect of pH on
Ingredients % in cleansers (wiw) the efficacy of soaps. AMI-7 and AMI-16 soaps were tested as
GSE O. 1-0.5
described in Example 14.
Citric acid O-1.O
1.3 propanediol O.S.-S.O TABLE 74
Benzyl alcohol O.25-S.O
Lemongrass oil O-O.S Rapid antimicrobial activity (30 second Kill)
Cinnamon oil O-O.S (Test Organism S. aureus)
Orange oil O-O.2 LoglO reduction from control growth
TetraHydrocurcuminoids O-O.2
Alkanediols (Pentanediol, O-1.O pH 3.2 pH 4.0 pH 5.0
Octanediol, Decanediol)
Ethanol O-10 AMI-7 Soap 7.5 3.1 1.3
AMI-16 Soap 7.2 3.2 1.4
Conclusion: Efficacy decreases with an increase in pH. The soap compositions are more
0221) The following table provides a specific AM-AI skin effective at pH below 5.0.
cleanser formulations containing the following ingredients
were prepared and tested. Example 16
TABLE 72 0225. The present example evaluates the efficacy of soaps
Ingredients containing various synergistic combinations of botanicals
(% w/w) AM-AI - 7 AM-AI - 16 AM-AI - 17 AM-AI - 18 with benzyl alcohol and ZemeaR) mixtures.
GSE O.2 O.2 O.S O.S
0226 Botanicals such as cinnamon oil (CO), lemongrass
Lemongrass oil O.3 O.3 O.3 O.3 oil (LG), basil oil, (BO), pomegranate oil (PO), and a mixture
Orange oil O.1 O.1 O.1 O.1 of edible plant extracts Kefiprotect (KP) were combined with
Benzyl alcohol O.S 1.O O.S 1.O synthetic benzyl alcohol (BA) and ZemeaR). Ethanol (SDA
Zemea (R) 1.O 1.O 1.O 1.O 3C) was used to adjust the total amount of the composition to
Citric acid 1.O 1.O 1.O 1.O
THC O O.15 O O.15 6.5 gms. These formulations were incorporated into a plain
Ethanol (SDA-3C) 4.9 4.25 4.6 3.95 Soap. Their activity against S. aureus after 30 second expo
sure was determined using Method 2 described above. The
pH of all the soaps ranged from 3.8-4.0
US 2012/020 1902 A1 Aug. 9, 2012

0227. The following cleanser compositions were prepared

and tested for efficacy after a 30 second exposure period. TABLE 76-continued
SDA3C 4.1
TABLE 75 Phospholipid PTM O.S
Incroquat O.S
Activity against Plain soap 93.5
S. aureus Soap - GP Grapeseed oil O.2
Soap Ingredient % Wiw (logio reduction) BA O.S
TM
Soap - L+ LG O.3 1. C S.
ze? (R) 9. Phospholipid PTM O.S
Incroquat O.S
SD d 3. Plain Soap 93.5
Plain soa 93.5 2.9 Soap- LGP LG O.30
p Grape seed oil O.15
Soap - B+ BO O.3 2.7 Orange oil O.1
BA O.S BA O.S
Zemea (R) O.S Zemea TM O.S
SDA 3C
Citric acid
4.7
O.S
SDA3C 3.95
Phospholipid PTM O.S
Plain Soap 93.5 Incroquat O.S
Soap - C+ BO O.3 Plain soap 93.5
BA O.S
Zemea (R) O.S
SDA3C 4.7
Citric acid O.S
Plain Soap 93.5 2.9 Example 17
Soap - KP+ S. g 0229. The p
e t
present pl evaluates
example luat rani
pidly acting
actin
Zemea (R) O.S botanical AM-AI hand disinfectant lotion. The following
SDA3C 4.7 Table provides a general formula for the AM-AI composi
E. acid
alin Soap
o: 2.5 tions comprising GSE, benzyl alcohol, Zemea, THC and a
Soap OPO- PSO O.3 coconut based phospholipid for a hand sanitizing lotion.
BA O.S
Zemea (R) 0.5 TABLE 77
SDA3C 4.7
Citric acid O.S Ingredients % (w.fw)
Plain soap 93.5 2.6
GSE 0.2-1.0
Conclusion: All of the soap formulations showed significant activity, Benzyl alcohol OS-2.O
Zemea (R) O.S.-S.O
THC O.O2-0.2
Example 16A SDA 40-B Natural alcohol 5-15
Incroquat Behenyl TMS O-2.O
0228. The present example provides formulations of soaps Hydroxypropyl O-O.S
containing phospholipid PTM Methylcellulose (Methocel)
gp p p Polygyaternium 10 O.OS-O.S
Arlasilk phospholipid PTM OS-2.O
TABLE 76 (coconut derived)
Water 30-70
Soap -LP LG O.3 pH 3.O-6.O
Orange oil O.1
BA O.S
Zemea TM O.S 0230. The following formulations were prepared. pH was
adjusted to 5.0.

TABLE 78
% (w.fw) % (w.fw) % (w.fw) % (w.fw) % (w.fw) % (w.fw) % (w.fw)
ngredients HS-1 HS-2 HS-3 HS-4 HS-5 HS-6 HS-7
GSE O.S O.S O.S O.S O.S O.S O.2
BA 1.O O O.S O.S O.S O.S O.S
Zemea (R) 1.O O O.S O.S O.S O.S O.S
THC O.15 O.15 O.OS O.OS O.OS O.OS O.OS
Citric acid 1.O O
LG O.1
PO O.OS
Octoxyglycerin O
SDA 40-B 10 9.0 10 10 10 10 10
Natural alcohol
incroquat Behenyl 1.O O 1.O 1.O
TMS
Polyguaternium 10 O.15 O.15 O.15 O.15 O.15 O.15 O.15
Symrise PCL liquid 1.O O
OO
US 2012/020 1902 A1 Aug. 9, 2012
33

TABLE 78-continued
% (w.fw) % (w.fw) % (w.fw) % (w.fw) % (w.fw) % (w.fw) % (w.fw)
Ingredients HS-1 HS-2 HS-3 HS-4 HS-5 HS-6 HS-7
Arlasik O.S O.S 1.O O.S 1.O O.S 1.O
phospholipid PTM
Hydroxypropyl O.15 O.15 O.15
methylcellulose
(Methocel)
Water 83.6 83.65 86.3 86.8 87.15 87.65 87.45

TABLE 79 TABLE 82
% (w.fw) % (w.fw) % (w.fw) Ingredients % (w.fw)
Ingredients HS-8 HS-9 HS-10
AM-AI antifungal cream 1 White Petrolatum 4.0
GSE O.S O.S O.S Stearyl Alcohol S.6
BA O.S O.S O.S Polyguaternium 10 O.24
Zemea TM O.S O.S O.S Inroquat Behenyl TMS 2.4
THC O.OS O.OS O.OS Polowax NF 2.4
SDA 40-B 10.325 11.9S 11.95 Isopropyl Myristate 3.2
Natural alcohol Sorbitan Oleate 1.6
Incroquat Behenyl O.S 1.O Polyoxyl 40 Stearate 1.6
TMS Propylene Glycol 1.6
U-care Jr 0.075 O.15 O.15 Benzyl alcohol 1.O
Arlasilk phospholipid O.S O.S Grape seed extract O.2
PTM Tetrahydrocucuminoid O.15
Hydroxypropyl O.15 Zemea (R) 1.O
methylcellulose Phospholipid PTM O.S
(Methocel) Water 74.51
Water 87.55 84.85 85.7 AM-AI antifungal cream 2 White Petrolatum 4.0
Stearyl Alcohol S.6
Polyguaternium 10 O.24
Evaluation of efficacy. Method 2 was used to test these hand Inroquat Behenyl TMS 2.4
disinfectant lotions. Polowax NF 2.4
Isopropyl Myristate 3.2
Sorbitan Oleate 1.6
TABLE 8O Polyoxyl 40 Stearate 1.6
Propylene Glycol 1.6
Rapid antimicrobial activity (30 second Kill) Benzyl alcohol 1.O
(Test Organism S. aureus) Grape seed extract O.2
Log10 reduction from control growth Tetrahydrocucuminoid O.1
Kefiprotect (R) O.1
HS-1 3.0 Zemea (R) 1.O
HS2 3.3 Lactic acid O.S
HS-3 4.8 Water 74.46
HS-4 3.5 AM-AI antifungal cream 3 White Petrolatum 4.0
HS-5 4.8 Stearyl Alcohol S.6
HS-6 3.8 Polyguaternium 10 O.24
HS-7 4.5 Inroquat Behenyl TMS 2.4
S. Polowax NF 2.4
Isopropyl Myristate 3.2
HS-10 S.6 Sorbitan Oleate 1.6
7 Polyoxyl 40 Stearate 1.6
Bacterial growthin Control (PBS) ranges from 2.0-2.2 x 10'. Propylene Glycol 1.6
Benzyl alcohol 1.O
Grape seed extract O.2
Example 18 Tetrahydrocucuminoid O.15
Lemongrass oil O.S
0231. The present example describes general and specific Zemea (R) 1.O
formulations for AM-AI compositions for topical creams. Lactic acid O.S
Octanediol 1.O
Water 73.01
TABLE 81 AM-AI antifungal cream 4 White Petrolatum 4.0
0A Stearyl Alcohol S.6
General formula yo in cleansers (ww) Polyguaternium 10 O.24
GSE O. 1-0.5 Inroquat Behenyl TMS 2.4
Lactic acid O-O.S Polowax NF 2.4
1.3 propanediol (Zemea (R) O.5-1O.O Isopropyl Myristate 3.2
Benzyl alcohol O.S.-S.O Sorbitan Oleate 1.6
Lemongrass oil O-O.S Polyoxyl 40 Stearate 1.6
TetraHydrocurcuminoids O-O.2 Propylene Glycol 1.6
Benzyl alcohol 1.O
US 2012/020 1902 A1 Aug. 9, 2012
34

TABLE 82-continued TABLE 85-continued

Ingredients % (w.fw) % (w.fw) % (w.fw) % (w.fw) % (w.fw)
Ingredients AHS-1 AHS-2 AHS-3 AHS-4
Grape seed extract O.2
Tetrahydrocucuminoid O.15 Hydroxypropyl O.OS O.OS
Lemongrass oil O.S methylcellulose (Methocel)
Zernea (R) 1.O Water 3O4 29.9 29.45 28.9S
Octoxyglyerin 1.O
Lactic acid O.S
Water 73.01 0235 Evaluation of efficacy. Method 2 was used to test
these alcohol hand disinfectants.

Example 19 TABLE 86
0232. The present example provides formulations for Rapid antimicrobial activity (15 second Kill)
alcohol-based hand sanitizer compositions. (Test Organism S. aureus)
Log10 reduction from control growth
TABLE 83 AHS-1 >7.O
AHS2 >7.O
Ingredients % in cleansers (ww) AHS-3 >7.O
AHS-4 >7.O
GSE O. 1-0.5
Lactic acid O-O.S Bacterial growthin Control (PBS) ranges from 2.0-2.2 x 10.
1.3 propanediol (Zemea (R) O.S.-S.O
Benzyl alcohol O.S.-S.O
Lemongrass oil O-O.3
Octoxyglycerin O-3.0 Example 2O
Ethyl alcohol 40-70
Water
TetraHydrocurcuminoids 10-30
O-O.1 0236. The present example provides a formulation for an
Pomegranate oil O-O.1 AM-AI topical cream Acne treatment.
TABLE 87
0233. The present example also provides formulations
containing GSE, benzyl alcohol, Zemea R, THC, and a coco- Ingredients % in cleansers (wiw)
nut based phospholipid for alcohol-based hand sanitizer GSE O.1-0.5
(AHS) compositions. Salicylic acid O.S.-3.0
Lactic acid O-O.2
TABLE 84 1.3 propanediol (Zemea (R) O.S.-S.O
Benzyl alcohol O.S.-S.O
Ingredients % (w.fw) Cinnamon oil O.1-0.3
Octoxyglycerin O-3.0
GSE 0.2-1.0 TetraHydrocurcuminoids O.04-0.2
Lactic acid O.2-2.O
1.3 propanediol (Zemea (R) O.S.-S.O
Benzyl alcohol OS-2.O
Water 30-70 Example 21
TetraHydrocurcuminoids O.O2-O2
SDA 40-B natural alcohol 60-80
Incroquat Behenyl TMS O-O.3 0237. The present example provides general and specific
Polyguaternium 10 O.OS-O.3 formulations for AM-AI veterinary products.
Arlasilk phospholipids PTM OS-2.O
(coconut derived)
SymsitiveTM 1609 (Symrise) O-1.O TABLE 88
pH adjusted to 3.0-6.0
General Formulation
Ingredients % (w.fw)
0234. The following specific formulations were prepared. Safflower oil 10-20
Lemongrass oil O-O.3
TABLE 85 Water 50-70
Xanthum gum O-O.S
% (w.fw) % (w.fw) % (w.fw) % (w.fw) Zinc lactate O-O.2
Ingredients AHS-1 AHS-2 AHS-3 AHS-4 Symrelief (Bisabolol + Ginger extract) O-O.2
Curcumin O-O.2
GSE O.2 O.2 O.2 O.2 PSO O-O.2
Benzyl alcohol O.S O.S O.S O.S Benzyl alcohol O-S.O
Zemea (R) O.S O.S O.S O.S 1.3 propanediol O-S.O
Ethyl alcohol 67.2 67.2 67.2 67.2 Calendula oil O.5-0.1
THC O.OS O.OS O.OS O.OS Glycerin S-12
Incroquat Behenyl TMS 1.O 1.O Grape fruit seed extract O.2-3.0
Polyguaternium 10 O.1 O.1 O.1 O.1 Lactic acid O.2-0.5
SymsitiveTM 1609 (Symrise) O.S O.S pH adjusted with 10N NaoH 6.5-6.7
Arlasilk phospholipid PTM 1.O 1.O 1.O 1.O
US 2012/020 1902 A1 Aug. 9, 2012
35

formly applied on the surface of the plate. The plates were

TABLE 89 incubated for 1 hour at 37°C. The plate was rinsed with 9.4 ml
Mastitits treatment lotion 1 % (w.fw) of drug neutralizing fluid (DNF). The rinse fluid was col
lected and serially diluted. The dilutions were plated on TSA.
Safflower oil 17.0
Lemongrass oil O.1 The plates were then incubated at 37°C. for 24-48 hours. As
Water 67.75 a control, 0.3 ml PEBS was spread uniformly on a plate and
Xanthum gum O45 processed in the same manner as the lotion.
Zinc lactate O.2
Symrelief (Bisabolol + Ginger extract) O.2 TABLE 93
Calendula oil O.S
Glycerin 10.6
Grape fruit seed extract 3.0 Efficacy of Mastitis lotion 1
Lactic acid O.2 against S. aureus logio reduction
pH adjusted with 10N NaoH 6.5-6.7 Lotion CFU plate from control growth
Control 3.1 x 10
Lotion 1 2.9 x 10' 4.3
Lotion 2 1.8 x 10 4.4
TABLE 90
Mastitits treatment lotion 2 % (w.fw)
0240. The following cow teat dip solution was prepared.
Safflower oil 17.0
Water 66.9 TABLE 94.
Xanthum gum O45
Hydroxycurcuminoid O.15 Cow teat dip Solution ingredients % (w.fw)
Benzyl alcohol 1.O
Symrelief (Bisabolol + Ginger extract) O.2 Safflower oil 1O.O
Calendula oil O.S Water 74.1
Glycerin 10.6 Xanthum gum O45
Grape fruit seed extract 3.0 Hydroxycurcuminoid O.15
Lactic acid O.2 Benzyl alcohol 1.O
pH adjusted with 10N NaoH 6.5-6.7 Zemea (R) 1.O
PCL liquid 100 (Symrise) 1.O
Calendula oil 0.5
Glycerin 10.6
TABLE 91 Grape fruit seed extract 1.O
Lactic acid O.2
Mastitits treatment lotion 3 % (w.fw) pH adjusted with 10N NaoH 6.5-6.7
Safflower oil 17.0
Water 61.54
Xanthum gum O45 Example 22
Hydroxycurcuminoid O.15
Benzyl alcohol 1.O
Pomegranate seed oil O.1 0241 The present example provides a specific formula
Calendula oil O.S
Glycerin 10.6 tions for a topical cream product.
Grape fruit seed extract 3.0
Lactic acid O.2 TABLE 95
pH adjusted with 10N NaoH 6.5-6.7
Topical cream ingredients % (w.fw)
Petrolatum 9.68
TABLE 92 Stearyl alcohol 14.52
Isopropyl myristate 4.84
Sorbitan oleate 2.42
Mastitits treatment lotion 4 % (w.fw) Polyoxy 40 stearate (Myri 52) 6.OS
Safflower oil 17.0 Germal + O.3
Water 68.0 Propylene glycol 4.0
Zinc lactate O.2
Xanthum gum O45 Zinc oxide O.3
Hydroxycurcuminoid O.15
Benzyl alcohol 1.O Calendula oil 1.O
Zemea (R) 1.O Silver sulfadiazine 1.O
Pomegranate see oil O.1 Benzyl alcohol O.S
Calendula oil O.S THC 0.075
Glycerin 10.6 1.3 propanediol O.S
Lactic acid O.O6
Grape fruit seed extract 1.O Water 54.56
Lactic acid O.2
pH adjusted with 10N NaoH 6.5-6.7

0238. The antibacterial efficacy of the Mastitis treatment Example 23

lotions was evaluated using the following methodology.
0239 Method 3. Trypticase soy agar (TSA) plates were 0242. In the present example, central venous polyurethane
seeded with 0.3 ml of 10 cfu of bacteria/ml and dried for 10 catheters were coated with the following solution and tested
minutes at room temperature. 0.3 ml of the lotion was uni for efficacy.
US 2012/020 1902 A1 Aug. 9, 2012
36

TABLE 96 TABLE 98-continued

A. B Ingredients % (w.fw)
Coating solution ingredients % (w.fw) % (w.fw)
Polyguartenium 10 O.O-O.2
Chlorhexidine 3.5 2.5 Hydroxyl propyl methyl cellulose O.O-O.3
Silver sulfadiazine 0.75 0.75 Water SO.O-900
Decanediol O.S Glycerine O.O-5.O
1.3 propanediol O.S Benzoic acid O.0-1.O
Benzyl alcohol O.S Bisbolol + Ginger extract O.O-O.1
THC O.OS
Polyurethane 60D 1.O 1.O
Polylurethane 93A 4.0 4.0 0247 Table 99 provides specific formulations for aqueous
Methanol 30 29.5
Tetrahydrofuran 60.75 59.7 hand disinfectants.
Lactic acid 1.O TABLE 99
Ingredients #18 #19 #2O #21 #29
0243 The catheters were tested for their antibacterial
activity using the following Zone of inhibition test method. Pomegranate 2.0 1.O O O O
seed oil
Catheter segments of 0.5 cm in length were tested in vitro for Kefiprotect O O 2.0 1.O 4.0
their ability to inhibit microbial growth using agar diffusion Benzyl alcohol 1.O 2.0 1.O 2.0 1.O
assay. Test catheters segments were vertically embedded in 1.3 Propanediol 2.0 2.0 2.0 2.0 2.0
TSA plates seeded with 10 cfu/ml of bacterial culture (10° Citric acid
Glucopon
O.2
1.O
O.2
1.O
O.2
1.O
O.2
1.O
O.2
1.O
cfu/ml for C. albicans). To evaluate the retention of inhibitory 215UP
activity, after recording the Zone of inhibition on the first day, SDA3C 8.8 8.8 8.8 8.8 7.0
catheter segments were transferred daily to fresh TSA plates. Base26 8S.O 8S.O 8S.O 85.0 85.0
The Zone of inhibition was then measured.
*Mixture of fermented oregano and thyme plant extracts
TABLE 97
0248 Table 100 provides additional specific formulations
Zone of inhibition (mm) Zone of inhibition (mm) for aqueous hand disinfectants containing benzyl alcohol, 1.3
Test organism A. B propanediol, and botanicals.
S. airetts 11.5 13.5 TABLE 100
Paeruginosa 7.0 12.O
C. albicans 1O.O 14.O Ingredients #22 #23 18LA 18LAK 18LAKS

Conclusion: Benzyl alcohol, 1.3 propanediol and THC enhances the efficacy, Pomegranate O.2 O O O O
seed extract
Ursole O O.2 O O O
Kefiprotect O O O O.O24 1.O
Example 24 Grapefruit O O 2.0 2.0 2.0
seed extract
0244. The present example provides an evaluation of rapid Benzyl 2.O 2.0 O6 O.6 O.6
antibacterial activity by antimicrobial compositions contain alcohol
ing benzyl alcohol. 1,3-propanediol, and botanicals (essential 1,3
Propanediol
2.O 2.0 O6 O.6 O.6
oils, fruit acids and botanical extracts). Citric acid O O.2 O.2 O O
0245 Method A: 0.8 ml of a test solution was mixed with Lactic acid O O O.2 O.2 O.2
0.1 ml of bacterial culture (10 cfu/ml) and 0.1 ml of bovine Glucopon
215UP
1.O 1.O O O 1.O
serum and vortexed for 15 seconds. 9 ml of drug neutralizing SDA 4OB 7.0 7.0 9.0 9.0 8.O
Fluid (DNF) was then added and serially diluted with DNF Water 2.8 2.6 2.4 2.576 1.6
and plated on trypticase Soy agar (TSA) plates. The plates Base26 85.2 8S.O 84.8 84.976 85.0
were incubated for 24-48 hours at 37°C., and colony counts
were determined. For a control, a gel base was used alone.
The gel base (Base 26) contains 0.2% hydroxymethylpropyl 0249 Table 101 provides an evaluation of the in vitro rapid
cellulose and 0.2% polycuaternium10, and 0.5%. 1.3 pro (15 seconds) antibacterial efficacy of an aqueous hand disin
panediol in water. fectant containing various Botanicals against S. aureus.
0246 Table 98 provides a general formulation for aqueous TABLE 101
hand disinfectants containing benzyl alcohol, 1.3 pro
panediol, fruit acid, and botanicals. Group logo reduction from control growth
18 2.63
TABLE 98 19 5.78
2O 2.36
Ingredients % (w.fw) 21 4.54
22 2.93
Botanical extract 0.0-4.0 23 2.44
Benzyl alcohol O.5-4.O 29 2.35
Aliphatic alcohol (C1-4) O.O-10.0 18LA 7.34
Fruit acid (Lacticfcitric acid) 0.2-4.0 18LAK 7.5
Alkylglycoside O.0-2.O
US 2012/020 1902 A1 Aug. 9, 2012
37

0250 Table 102 provides a general formulation for a stock

Solution of aqueous hand disinfectant containing higher con TABLE 105-continued
centrations of benzyl alcohol. The stock solution is used in Ingredients 18LA 4 18LAS 37B 1.8LA4-S 18LA6 18LA7
various personal care products in amounts ranging from 2.0-
20% (w/w). Base26 85.0 85.0 85.0 84.95 8O.O 8O.O
Symrelief O O O O.OS O O
TABLE 102
Ingredients % (w.fw) Range
Botanical extract 10.0-2O.O
Example 25
Fruit acid O.5-4.O
Benzyl alcohol 5.0-100 0255. The present example provides an evaluation of syn
Propanediol 5.0-100 ergistic antibacterial activity of the combination of (1) benzyl
alcohol and fruit acids; and (2)benzyl alcohol and biguanides
0251 Table 103 provides specific formulations of aqueous or benzalkonium chloride with and without fruit acids.
hand disinfectant containing higher concentrations of benzyl 0256 The present example evaluates rapid (15 seconds)
alcohol. antibacterial activity of various agents, alone and in combi
nation, in an aqueous gelbase (Base26) using S. aureus as the
TABLE 103 test organism. One method of testing (Method A) uses 0.8 ml
Ingredients 18LA1 18LA2 37 37A
of the test solution mixed with 0.1 ml of bacterial culture (10
cfu/ml) and 0.1 ml of Bovine serum. The solution is vortexed
Grapefruit seed 2.O 2.0 O 2.0 for 15 seconds. 9.0 ml of drug neutralizing Fluid (DNF) is
extract
Benzyl alcohol 1.O O6 2.0 2.0
then added and then serially diluted with DNF and plated on
1.3 Propanediol 1.O O6 3.0 3.0 TSA plates. Plates are incubated for 24-48 hours at 37° C. and
Lactic acid O.2 O.2 2.0 2.0 colony counts were determined. For A control, the base was
Glucopon 215UP 1.O 1.O 1.O 1.O used alone.
SDA3C 8.0 8.0 7.0 7.0
Water 1.8 2.55 O O (0257 Table 106 provides rapid antibacterial activity
Symrelief
Base26
O
85.0
O.OS
85.0
O
85.0
O.OS
82.95
(logo reduction from the control growth) with the organism
S. aureus.

0252 Table 104 shows in vitro rapid kill (15 seconds) data TABLE 106
for aqueous hand disinfectant containing higher concentra Group (% w/w) logio reduction
tions of benzyl alcohol.
Benzyl alcohol 0.5 O.13
TABLE 104 Benzyl alcohol 1.0 O.14
Benzyl alcohol 2.0 O.18
log in reduction from control growth Benzyl alcohol 3.0 O.2
3 Propanediol 3.0(PD) O.2
Organism 18LA 18LA1 37 Lactic acid (LA) 0.2 O.1
Lactic acid 2.0 O.11
E. coi 7.06 7.06 7.8O Citric acid (CA) 0.2 O.1
S. airetts 7.14 7.14 4.71 BAO.5 + LAO.2 O.10
BAO.5 + LA 2.0 O.13
BA1.0 + LA 2.0 1.93
BA2.0 + LA2.0 4.21
0253) These results demonstrate that botanicals, in par BA3.0 + LAO.2 3.24
ticular GSE and pomegranate seed extract, show good activ BA3.0 + LA2.0 4.4
ity when used in combination with benzyl alcohol and fruit BA3.0 - CAO.2 2.9
acid. Benzyl alcohol at higher concentrations along with fruit PD 3.0 - L.A. O.2
BA3.0 - PD3.0 - LAO2
O.S
3.24
acid are also effective without any botanical extracts. BA3.0 - PD3.0 - LA2.O 4.4
0254 Table 105 shows specific formulations of aqueous BA2.0 - PD3.0 - LA2.O 4.21
hand disinfectants containing higher concentrations of benzyl BA6.O- PD 6.O- LA 2.0 7.0
alcohol. Benzalkonium chloride (BZK) 0.1 2.7
BZKO.1 + citric acid O.2 2.2
PD3.0+ BZKO.1 + Citric0.2 1.9
TABLE 105 BA3.0+ PD3.0+ citric0.2 2.7
BA3.0 - PD3.0 - BZKO1 2.69
Ingredients 18LA 4 18LAS 37B 18LA4-S 18LA6 18LA7 BA3.0 + Citric0.2 + BZKO.1 7.3
BA3.0+ PD3.0+ citric.0.2 + BZKO.1 7.3
Grapefruit 1.O 1.O O.O 1.O 2.0 O.O BA3.0+ PD3.0+ actic.0.2 + BZKO.1 7.5
seed exrtract Chlorhexidine gluconte (CHG) 0.2 1.43
Benzyl alcohol 2.0 2.0 2.0 2.O 2.0 2.0 Chlorhexidine gluconate 0.5 2.4
Kefiprotect O O O O O 2.0 BA3.0 + PD3.0+ actic acidO.2 + CHGO.2 4.97
1.3 Propanediol 3.0 3.0 3.0 3.0 3.0 3.0 BA3.0+ PD3.0+ actic acid O.2 + CHG 0.5 7.37
Lactic acid 2.0 2.0 2.0 2.O 2.0 2.0
Glucopon 1.O 1.O 1.O 1.O 1.O 1.O
215UP
SDA3C 6.O O O 6.0 1O.O 1O.O 0258. The data demonstrates the following. Benzyl alco
Water O 6.O 7.0 O O O hol at 1% and more than 1% exhibits synergistic activity with
citric and lactic acid. 1.3 propanediol makes the Solution clear
US 2012/020 1902 A1 Aug. 9, 2012

and stable. Benzalkonium chloride (BZK) and chlorhexidine 0263 Tables 110 and 111 provide an evaluation of the in
exhibit synergistic activity with benzyl alcohol and fruit vitro rapid (15 seconds) antibacterial efficacy of aqueous
acids. hand disinfectant.
0259 Table 107 provides the results from the evaluation of
synergistic antibacterial activity of benzyl alcohol and vari TABLE 110
ous organic acids. Test organism 1 x 10
cfuml S. aureus
TABLE 107 logo reduction from
Group control growth S. auretts
Groups (% w/w) logo reduction
A. 6.48
Benzyl alcohol 2.0 O.12 D 3.16
Benzoic acid 2.0 O.1 28 S.48
Benzylalcohol.2.0 + benzoic acid2.0 6.2 28B 6.63
Ascorbic acid2.0 O.1
Benzyl alcohol + ascorbic acid2.0 O.1
Lactic acid 2.0 O.11
BA2.0 + LA2.0 4.21
Benzoicacid2.0 + Lactic acid 2.0 O.1 TABLE 111
Benzoic 1.0 + Lactic1.0 + benzyl alcohol 2.0 4.0 Test organism 1 x 10 cfu/ml
logia reduction from control growth
0260. The data demonstrates that benzoic acid, lactic acid Group S. airetts Paeruginosa
and combinations thereof exhibit synergistic activity with
benzyl alcohol. The organic acid ascorbic acid was not effec 28B 6.63 8.22
tive in this regard.
Example 26 Example 27
0261 The present Example evaluates a rapidly acting 0264. The present Example evaluates the activity of rap
aqueous hand disinfectant containing synergistic combina idly acting hand disinfectant Soaps containing benzyl alcohol,
tions of benzyl alcohol, fruit acid, with or without benzalko propanediol, and fruit acid (BPF) with or without benzalko
nium chloride. The following Table provides a summary of a nium or triclosan. The method of testing is same method as
general formulation of Such compounds. described above as Method A, however using 10 organism
instead 10. Table 112 summarizes a general formulation for
TABLE 108 the compositions of hand disinfectant Soaps.
Ingredients % Range TABLE 112
Benzyl alcohol 1.0-50 ngredients % Range
1.3 Propanediol 1.0-50
Fruitacid O.2-2.O Benzyl alcohol 1.0-3.0
Benzalkonium chloride O.O-O.12 3 Propanediol 1.O-5.O
Alcohol O.O-10.0 Fruitacid O.2-2.O
Polyguartenium 10 O.O-O.2 Triclosan O.O-O.S
Hydroxypropyl methyl cellulose O.O-O.3 Biguanide O.O-O.S
Glycerine O.O-O.S Benzalkonium chloride 0.1-0.12
Bisbolol + Ginger extract (Symrelief) O.O-O.1 Benzethonium chloride O.O-O.18
Water SO.O-90.O Phenoxyethanol O.O-1.O
incromineoxideL S.O-1S.O
Montaline C 40 S.O-1O.O
0262 Table 109 provides below specific formulations for Crosultane C 50 3.0-S.O
compositions of aqueous hand disinfectants. Nonionic Surfactant O.S.-S.O
Dipropylene glycol O.O-5.O
Diglycerol O.O-5.O
TABLE 109 Glycerine O.O-5.O
Water 40.O-80.0

Ingredients 28 A. D 28 B 28C
0265 Table 113 provides certain specific formulas of hand
Benzalkonium chloride O.1 O.1 O.1 O.1 O.1 disinfectant Soaps.
Benzyl alcohol 3.0 3.0 O 3.0 3.0
1.3 propanediol 3.0 O O 4.0 4.0
Citric acid O.2 O.2 O O O TABLE 113
Lactic acid O O O O.2 O.2
% (w.fw
SDA3C 7.0 7.0 7.0 7.0 7.0
Base26 84.9 8S.O 85.0 8S.O 8S.O
14 15 16 14
Water 1.8 4.7 7.9 0.7 O.65
Symreleif O O O O O.OS Ingredients (BPC) 14Tc 14BZT (Tc) (Citric) (BZK)
Citric acid 1.O 1.O 1.O 1.O 1.O 1.O
Benzyl alcohol 2.0 2.0 2.O 2.0 O 2.0
The data demonstrate that the combination of benzyl Alcohol, Propane diol 1.O 1.O 1.O 1.O O 1.O
propanediol, citric acid, and benzalkonium chloride is more Phenoxy ethanol 1.O 1.O 1.O 1.O O 1.O
effective than benzalkonium chloride alone.
US 2012/020 1902 A1 Aug. 9, 2012
39

Table 116 provides for specific compositions of alcohol based

TABLE 113-continued hand sanitizers (ABHS).
% (w.fw
TABLE 116
14 15 16 14
% (w.fw
Ingredients (BPC) 14Tc 14BZT (Tc) (Citric) (BZK)
SDA 40 B 10 10 10 10 10 10 ABHS - ABHS
Triclosan O O.15 O O.15 O O Ingredients A-4 B-4 C-4 D-4 E-4 5 6
Benzethonium O O O.18 O O O
chloride Benzyl alcohol 1 1 1 1 1 1 1
Zemea 1 1 1 1 1 3 3
Benzalkonium O O O O O O.1
Lactic acid 2.O O.2 O.2 O.2 O O O
chloride
Water 58 57.85 57.82 57.85 62 57.9
Grape fruit O.2 O.2 O O O O O
seed extract
Incromine oxide 13 13 13 13 13 13
Chlorhexidine O O O.2 O O O O
Montalene 5 5 5 5 5 5
Dipropylene 5 5 5 5 5 5
gluconate
Polyhexamethyl O O O O O O.3 O.3
glycol biguanide
Crosultane C-50 3 3 3 3 3 3
Pronic F 87 NF 1 1 1 1 1 1 (PHMB)
Octanediol O O O O.S O.S O O
Lactic acid O O O O O.2 O.2 2.0
SDA3C alcohol 67.2 67.2 67.2 67.2 67.2 67.2 67.2
0266 Table 114 provides an evaluation of the invitro rapid Water 28.2 30 30 29.7 29.7 27.9 26.OS
(15 seconds) antibacterial efficacy of hand disinfectant soap Polyguartenium O.2 O.2 O.2 O.2 O.2 O.2 O.2
against S. aureus. 10
Hydroxypropyl O.2 O.2 O.2 O.2 O.2 O.2 O.2
TABLE 114 methy cellulose
Symrelief O O O O O O O.OS
Logo reduction from
Group control growth Table 117 provides an evaluation of the in vitro rapid (15
14 (BPC) 5.32 second) antibacterial efficacy of alcohol based hand disinfec
14TC 8.4 tants against MRSA.
14BZT 7.5
15 (TC) O.S TABLE 117
16 (Citric) O.3
BZKA 4.14
14BZK 6.60 logo reduction from
Group control growth
A-4 >8.0
In Table 114, “BZK A' is the soap formulation containing B-4 >8.0
14BZK except BPF and phenoxyethanol. “TC” is triclosan. C-4 >8.0
“The data demonstrate that triclosan and BZK exhibits syn D-4
E-4
>8.0
>8.0
ergistic action with BPC. “BZT is benzethonium chloride.
“BZK is benzalkonium chloride. “BPF is the combination
of benzyl alcohol, propanediol, and fruit acid. “BPC is the Table 118 provides the data for in vitro rapid kill (15 seconds)
combination of benzyl alcohol, propanediol, and citric acid. by ABHS 5.
Example 28 TABLE 1.18
0267. The present example relates to an alcohol based FDA TFM Method
hand disinfectant containing benzyl alcohol, propanediol and
lactic acid (BPL). Table 115 below provides the general for Logo reduction from %
mula for such alcohol based hand disinfectants. Organism control growth kill
MRSA 8.05 100
TABLE 115 S. airetts 8.45 100
Paeruginosa 8.2O 100
Ingredients % Wiw E. coi 8.57 100
K. pneumonia 3.84 99.98
Benzyl alcohol 1-5
1.3 propanediol (Zemea) 1-5
Lactic acid 0.2-4
Benzoic acid O-2
Grape fruit seed extract 0.2-2
Example 29
Chlorhexidine gluconate O-O.2 0268. The present example relates to alcohol-based broad
Polyhexamethylbiguanide (PHMB) O-O.3
Octanediol O-1.O spectrum rapidly acting wash off hand disinfectant contain
Aliphatic Alcohol 60-70 ing BPL.
Water 20-30 0269. Regular and proper hand washing has been empha
Polyguartenium 10 O.1-0.3 sized as an important infection control strategy by the Centers
Hydroxypropyl methy cellulose O.1-0.3
Symrelief O-O.1 for Disease Control and Prevention. Increased compliance
Aloe barbadensis juice O-1.O with hand washing has been shown to significantly reduce
carriage of potential pathogens on the hands of healthcare
workers and has resulted in a significant reduction in noso
US 2012/020 1902 A1 Aug. 9, 2012
40

comial infection. Studies show that the rate of handwashing

compliance is lower than 50%. To address these problems, the TABLE 120-continued
use of alcohol-based sanitizers containing emollients has
been recommended. In addition to saving time, the use of Ingredients 2A 2B 2C 2D
alcohol-based products was reported to be more effective
than soap and water in reducing infections; however, alcohol Glycerine 1.O 1.O 3.0 3.0
based hand rub is not an option if the hands are visibly soiled Water 10.66 9.66 6.56 3.56
or contaminated with proteins and organic matter. See Girou Citric acid 1.O 1.O 1.O 1.O
etal, BMJ 325:362-367 (2002); Hilburn et al., Am. J. Infect, Incromine oxide 8.0 8.0 8.O 8.0
Control 31:109-116 (2003). Hand hygiene guidelines for L
healthcare personnel published by the Centers for Disease Pronic F87 NF 1.O 1.O 1.O 1.O
Control and Prevention recommend that alcohol-based hand Cocamidopropyl 8.0 8.0 8.O 8.0
gels and foams be used routinely, with intermittent thorough betaine
hand washing with Soaps throughout the day. Furthermore Masi SF 19 1.O 1.O
Alcohol-based products, have very poor activity against bac Aloe 1.O 1.O
terial spores Such as Clostridium difficile and against certain barbadensis
nonenveloped viruses. It has been reported that C. difficile juice
infection, which is associated with diarrhea, is frequently Symrelief O.1 O.1
transmitted among hospitalized patients via the hands of
healthcare workers caring for Such patients. Washing with
Soap can remove pathogens from the hands of hospital per Table 121 provides compositions of alcohol based broad
Sonnel. spectrum rapidly acting wash off hand disinfectant.
0270. To address this problem, an alcohol-based rinse off
hand disinfectant has been developed, which contains the TABLE 121
rapidly acting alcohol (60%), a rinse off cleansing disinfec ngredients 3C 3D 4C 4D 5C 5D
tant containing synergistic combination of combination of
Benzyl alcohol and fruit acid, emollients and foaming agents. SDA 40 B 64.84 64.84 64.84 64.84 64.84 64.84
When this product is applied on the hand the alcohol rapidly Klucel 1.O 1.O O.S O.S
KM O.3 O.3 O.3 O.3
inactivates the pathogens and evaporates off within a minute. Polyquartenium10 O.2 O.2
Then the hand is lathered with water for 15 seconds and then Benzyl alcohol 2.0 2.0 2.0 2.0 2.0 2.0
rinsed off. 3 Propanediol 2.0 S.O 2.0 S.O 2.0 S.O
Phenoxyethanol 1.O 1.O 1.O 1.O 1.O 1.O
0271 The compositions in the present Example are alco Glycerine 3.0 3.0 3.0 3.0 3.0 3.0
hol based broad spectrum rapidly acting wash off hand dis Water 6.06 3.06 6.26 3.26 6.S6 3.56
infectant. Table 119 provides the general formula for the Citric acid 1.O 1.O 1.O 1.O 1.O 1.O
compositions containing BPL. incromine oxide L.
Pronic F87 NF
8.0
1.O
8.0
1.O
8.0
1.O
8.0
1.O
8.O
1.O
8.O
1.O
Cocamidopropyl 8.0 8.0 8.0 8.0 8.O 8.O
TABLE 119 Beataine
Ingredients % Wiw Masi SF 19 1.O 1.O 1.O 1.O 1.O 1.O
Aloe barbadensis 1.O 1.O 1.O 1.O 1.O 1.O
Aliphatic alcohol (C1-6) 60-70 uice
Hydroxy propyl cellulose O.5-1.O
Incroquat Behenyl TMS 50 0.2-1.0 Symrelief O.1 O.1 O.1 O.1 O.1 O.1
Benzyl alcohol 10-5.O
1.3 Propanediol 10-5.O
Glycerine 10-5.O
Water 5.0-2O.O Table 122 provides a composition of an alcohol based broad
Lactic acid
Benzoic acid
O.2-2.O
O-1.O
spectrum rapidly acting wash off hand disinfectant (ABHS
Incromine oxide L. 3.0-10 5-E).
Pronic F87 NF O.5-2.O
Cocoamidopropyl betaine 5.0-100 TABLE 122
Masi SF 19 O.5-2.O
Aloe barbadensis Juice O.S-20 ABHS 5-E Ingredients % Wiw
Symrelief O-O.1
SDA 40 B 64.84
Hydroxy propyl cellulose 1.O
Table 120 provides specific formulations for the alcohol Incroquat Behenyl TMS 50 O.S
Benzyl alcohol 2.0
based, wash-off, hand disinfectants. 1.3 Propanediol S.O
Glycerine 3.0
TABLE 120 Water 6.56
Lactic acid 1.O
Ingredients 2A 2B 2C 2D Incromine oxide L. S.O
Pronic F87 NF 1.O
SDA 40 B 64.84 64.84 64.84 64.84 Cocoamidopropyl betaine 8.0
Klucel O.S O.S O.S O.S Masi SF 19 1.O
Benzyl alcohol 2.0 2.0 2.0 2.0 Aloe barbadensis Juice 1.O
1.3 Propanediol 2.0 3.0 2.0 S.O Symrelief O.1
Phenoxyethanol 1.O 1.O 1.O 1.O
US 2012/020 1902 A1 Aug. 9, 2012
41

Table 123 provides the results from an in vitro rapid kill (15
seconds) of ABHS 5E. TABLE 126
TABLE 123 Logio reduction
Groups from control
FDATFM Method
S5 O.84
logio reduction %
Organism from control growth kill S7 2.67
S8 4.16
MRSA 8. OS 100 S9 1.20
S. airetts 8.45 100
Paeruginosa 8.2O 100
E. coi 8.57 100
0274 The data shows that Vantocil exhibits synergistic
activity with benzyl alcohol and lactic acid. Table 87 provides
Example 30 a further evaluation of synergistic activity of biguanide (Van
tocil), benzyl alcohol, and fruit acids. The following ingredi
0272. The present Example provides a surface disinfec ents were added in a Surfactant base containing water and
tants composition containing benzyl alcohol, fruit acid and alkyl polyglycoside surfactant (Glucopon) (Table 127).

TABLE 127
% Wiw

Ingredient
Vantocil O.3 O.15 O.15 O.15 O.15 O15 O.15
Glucopon 1.O 1.O 1.O 1.O 1.O 1.O 1.O 1.O 1.O
Citric acid 2.0 2.0 2.0 2.0
Lactic acid 2.0 2.0 2.O
Benzyl alcohol 1.O 1.O 2.0 2.O 2.0 2.0
SDA3C 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0
Water 91.7 89.85 89.85 88.85 88.85 87.85 87.8S 90.0 88.0

biguanide. Table 124 provides the general formulation for Table 128 provides the results from an in vitro rapid (15
Such compounds. second) antibacterial efficacy of Surface disinfectants against
TABLE 124 S. aureus.
Ingredient % Wiw TABLE 128
Vantocil O. 1-0.5
Glucopon (alkyl Polyglycoside) O.S.-3.0 Logio reduction
Lactic acid O.2-2.O
Citric acid O-2O Groups from control
Benzoic acid O-1.O
Benzyl alcohol O.5-10.0 T1 2.80
Aliphatic Alcohol O-10
Water 80-95 T2 2.95
T3 3.02
T4 4.12
0273. An evaluation of synergistic activity was carried out T5 4.03
of biguanide (Vantocil), benzyl alcohol, and fruit acids. The
following ingredients were added in a surfactant base con B7 5.45
taining water and alkyl polyglycoside Surfactant (Glucopon) B8 7.28
(Table 125). T8 1.41

TABLE 125 T9 1.83

Ingredient S5 S7 S8 S9
Vantocil O.15 O.15 O.15 Conclusion: Vantocil exhibits synergistic activity with Ben
Glucopon
Lactic acid
1.O 1.O
O.2
1.O
O.2
1.O
O.2
Zyl alcohol and fruit acids
Benzyl 1.O 1.O
alcohol
Water 98.85 98.65 97.65 97.8
Example 31
0275. The present example evaluates an antifungal diaper
Table 126 provides the dadta for an in vitro rapid (15 second) rash cream/antifungal skin cream containing BPL. This
antibacterial efficacy of Surface disinfectants against S. cream contains the following agents in a hydrophilic cream
Ca,S. base benzyl alcohol, tetrahydrocurcuminoid, fruit acid and
US 2012/020 1902 A1 Aug. 9, 2012
42

chemical antibacterial miconazole, and preservative levels of (drug neutralizing fluid) was added to each piece, mixed to
chlorhexidine and BZK. Table 129 provides the formulation remove the cream and loosely adhered bacteria on the skin.
for antifungal skin cream 27. 0279 Loosely adhered organism: The fluid containing the
cream was removed, serially diluted with DNF and aliquots
TABLE 129 plated on TSA and incubated for 24-48 hours and colonies
were counted.
1. Water 6S.O2
2. Zinc gluconate O.10 0280 Tightly adhered organism: DNF was added to the
3. Polyguartenium 10 O.24 rinsed pigskin and Sonicated for 20 minutes to remove the
4. Incroquat Behenyl TMS
5. Polawax
3.2
3.2
tightly adhered bacteria. The fluid after sonication was seri
6. Petroleum Jelly 4.7
ally diluted, plated on TSA and, incubate for 24-48 hours and
7. Stearyl alcohol 7.4 colony counts were determined. Table 131 provides the evalu
8. Myri 52 2.8 ation of efficacy in the pig skin method (test organism C.
9. Zinc Oxide O.2O albicans).
10. Propylene Glycol 2.0
11. Isopropyl Myristate 3.30
12. Sorbitan Oleate 1...SO TABLE 1.31
13. Miconazole 2.0
14. Dipropyleneglycol 2.0 Loosely attached Tightly adhered
15. Benzyl alcohol O.8 organism organism
16. 1.3 Propanediol (Zemea) O.S Groups logo reduction from control
17. Tetrahydrocurcuminoid O.OS AF-27 3.31 3.9
18. Octanediol O.S
AF-M O.S4 0.27
19. Lactic acid (88% active) O.2
20. Benzalkonium chloride (Powder) O.09
21. Chlorhexidine gluconate O.2
0281 Method E: In vitro efficacy of AF creams against
Aspergillus niger. Cream was inoculated with A. niger culture
0276 An evaluation of the efficacy of thentifungal cream (10 cfu/gm) mixed well and incubated at 30° C. for 24 hours.
(AF-27) and miconazole cream (AF-M) was carried out. At the end of the incubation period, DNF was added, mixed,
AF-M 2%. Miconazole was added to the same cream base as serially diluted with DNF and plated on TSA for 30° C. for
27 except it does not contain Sand 15-21. 24-48 hours and colony counts were determined. Table 132
(0277 Method C: Zone of inhibition (test organism C. albi provides the efficacy data of AF creams on A. niger (24 hours
cans ATCC #11651). Table 130 provides the data for the Zone incubation).
of inhibition.
TABLE 132
TABLE 130
logio reduction
Groups from control
Zone of Inhibition (mm
AF-Z27 4.92
Groups C. albicans A. niger AF-M O.65
AF-Z27 19.5 19.5
AF-M 12.O 9.0
0282 Conclusion: Antifungal activity of miconazole can
be significantly enhanced by the use of synergistic combina
0278 Method D: Evaluation of efficacy in pigskin method tion of benzyl alcohol, fruit acid, biguanide and benzalko
(test organism C. albicans). Pigskin pieces were soaked in nium chloride.
Candida albicans culture (107 cfu/ml) and incubated at 37°C. Example 32
for 3 hours. The pigskins were removed, blotted with kim
wipes, and each piece was covered with the cream and incu 0283. The present Example provides various formulations
bated at 37° C. for 3 hours. At the end of incubation, DNF for antifungal diaper rash creams.

TABLE 133
Ingredients 28S 29S 3O 31A 31B 32 33A 33B
Water 49.21 43.21 41.85 36.15 36.25 41.8
Zinc gluconate O.10 O.1 O.1 O.2 O.2 O.2 0.4 0.4
Polyguartenium 10 O.24 O.24
Incroquat Behenyl TMS 3.2 3.2 3.6
Polawax 3.2 3.2
Mineral oil 2.O
White petrolatum - 11.O. 11.O 1 O.O 47.OS 46.95
Petroleum Jelly 4.7 S.6 S.6
Stearyl alcohol 7.4 8.9 8.9 16.O. 16.0 9.0 16.O. 16.0
Myri 52 PolyoxylAO) 2.8 3.4 3.4 6.7 6.7 6.5 6.7 6.7
Zinc Oxide 3.0 S.O 1.O.O. 10.O 100 S.O. 10.O. 10.0
Propylene Glycol 2.0 2.0 2.O
Isopropyl Myristate 3.30 4.0 6.O 6.O 6.0 6.O 6.O
Sorbitan Oleate 1...SO 1.8 2.7 2.7 2.7 2.7 2.7
Cetearyl alcohol 4.4
US 2012/020 1902 A1 Aug. 9, 2012

TABLE 133-continued
Ingredients 28S 29S 3O 31A 31B 32 33A 33B

Popyleneglycol S.O
Zinc stearate 2.O 2.O 2.O 4.0 4.0 4.0 4.O 4.0
Miconazole 2.O 2.O 2.O 2.0 2.0 2.0 2.O 2.0
Dipropyleneglycol 2.O 2.O 2.O
Benzyl alcohol O.8 O.8 O.8 1.O 1.O O.8 1.O 1.O
1.3 Propanediol (Zemea) O.S O.S O.S 3.0 3.0 O.S 3.0 3.0
Tetrahydrocurcuminoid O.OS O.OS O.OS O.OS O.OS O.OS O.OS O.OS
Octanediol O.S O.S O.S
Lactic acid (88% active) O.2 O.2 O.2 1.O 1.O O.2 1.O 1.O
Benzalkonium chloride O.1 O.1 O.1 O.1 O.1 O.1
(Powder)
Chlorhexidine gluconate O.2 O.2 O.2 O.2 O.2
Calendatia oil 1.O 1.O 1.O 1.O
Silicone D C 1403 S.O S.O — 5.0
Silicone D C 3225 C S.O S.O — 5.0
Butyleneglycol 2.O
Sorbitan Oleate 1.8

Example 33
TABLE 135-continued
0284. The Example provides the formulation for an anti
bacerial first aid cream containing BPL. % Wiw

TABLE 134 Ingredients A. A3 A4 AS

Propylene glycol 160 1.60 160 1.60
ngredients % (w.fw) Isopropyl myristate 3.21 3.21 3.21 3.21
Water 6SS1 Sorbitan Oleate 160 1.60 160 1.60
Zinc gluconate O.2O MyrS2 1.60 1.60 1.60 1.60
Polyguartenium 10 O.24 Pomegranate seed oil O.2 O.2 O.2 O.2
(ncroquat Behenyl TMS 3.2 Lactic acid O.2 O.2 O.2 O.2
Polawax 3.2 Benzyl alcohol 2.0 2.0 2.0 2.0
Petroleum Jelly 4.7 1.3 Propanediol 2.0 2.0 2.0 2.0
Stearyl alcohol 7.4 Tetrahydrocurcuminoid O.1 O.1 O.1 O.1
Myri 52 2.8 Mineral oil 1.O 1.O 1.O
Zinc Oxide OSO Fermented soy protein 2.0
Propylene Glycol 2.0 Resveratrol 2.0 2.0 2.0
sopropyl Myristate 3.30 Glycerine 2.0 1.O
Sorbitan Oleate 1...SO Aloe barbadensis Juice 1.O
Dipropyleneglycol 2.0
Benzyl alcohol O.8
3 Propanediol (Zemea) O.S 0286 Table 136 provides the data for the antimicrobial
Tetrahydrocurcuminoid O.OS
Octanediol O.S efficacy (Zone of Inhibition) for the test organism S. aureus.
Lactic acid (88% active) O.2
Calendula oil 1.O TABLE 136
Benzalkonium chloride (Powder) O.1
PHMB O.3 Zone of
Groups Inhibition (mm)
A. O
Example 34 A3
A4
9.0
9.0
0285. The present Example evaluates various antimicro
bial/wound healing topical creams containing BPL and
botanicals. Table 135 provides a summary of the cream for Example 35
mulations.

TABLE 135 0287. The present example provides formulations for oral
care compositions containing benzyl alcohol and fruit acids
% Wiw
with broad spectrum antimicrobial activity including antifun
Ingredients A. A3 A4 AS gal activity.
Water 72.84 67.84 67.84 67.84 0288 Ventillator associated pneumonia (VAP) has been
Polyguarternium 10 O.24 O.24 O.24 O.24 reported to result from oral pathogens adhering to the ventil
Incroquat Behenyl TMS 240 2.40 240 2.40 lator/endotracheal tubes and the use of Oral rinse containing
Polawax 240 2.40 240 2.40
Petroleum Jelly 4.OO 4.OO 4.OO 4.OO antibacterials such as chlorhexidine may prevent ventilator
Stearyl alcohol S.61 S.61 S.61 S.61 associated pneumonia. Table 137 provides a Summary of
formulations for various compositions of oral care products.
US 2012/020 1902 A1 Aug. 9, 2012
44

TABLE 1.37
% (w.fw

Ingredients OCP1. OCP2 OCP3 OCP4 OCP5 OCP6 OCP7 OCP8 OCP.9
Water 70.46 70.46 66.528 66.338 66.238 66.078 66.23S 76.737 76.587
Polyguaternium10 0.175 0.175 O O O O
Hydroxypropul 0.175 0.175 O O O O
cellulose
Glycerin 10 10 10 10 10 10 10 10 10
Sodium saccharin O.08 O.08 O.O8 O.08 O.08 O.08 O.08 O.O8 O.08
Pluronic F127 O.3 O.3 O.3 O.3 O.3 O.3 O.3 O.3 O.3
Sorbic acid O.1 O.1 O O O O
Potassium sorbate O.1 O.1 O O O O
Spearmint oil O.O1 O.O1 O O O O
Zinc salicylate O.OS O.OS O O.OS O.OS O.OS O.OS O.OS O.OS
Copper salicylate O.O2S O.O2S O.O2S
Thymol O.OS O.OS O.OS O.OS O.OS O.OS O.064 OO64 O.064
Menthol O O O.04 O.04 O.04 O.04 O.04 O.04 O.04
Eucalyptol O O O.O92 O.O92 O.O92 O.O92 O.092 O.O92 O.O92
Methyl salicylate O O O.O6 O O.O6 O.O6 O.O6 O.O6 O.O6
Benzyl alcohol O.6 O6 1.O 1.O 1.O 1.O 1.O 1.O 1.O
Grapefruit seed 2.0 2.0 O O O O
extract
3 propranediol O.6 O6 O O O O
Lactic acid O.2 O.2 O O.2 O.2 O.2 O.2 O.2 O.2
Sorbital solution O O O.1 O.1 O.1 O.1 O.1 O.1 O.1
Benzoic acid O O O.1 O.1 O.1 O.1 O.1 O.1 O.1
Sodium benzoate O O O.OS O.OS O.OS O.OS O.OS O.OS O.OS
Ethanol 15 15 21.6 21.6 21.6 21.6 21.6 11.104 11.104
Benzalkonium O.1 O O O O O
chloride
Chlorhexidine O O.1 O O O O
gluconate
Silver nitrate O O O O O.O2 O
Hydrogen peroxide O O O O O.O2 O
Sodium perborate O O O O O O.2
Chlorphyllin O.OO)4 O
Coloring agent O O.OO2 O.OO2
Citrus extract O.S O.S
Triclosan O.15

Table 138 provides the data for rapid antibacterial activity of

mouth rinse OCP 8 (Method A). TABLE 139
TABLE 138 Composition Use level in
logo reduction from in Stock cream (1-1.5%)
Organism control growth Range Range
S. airetts 3.6
Paeruginosa 4.14 Benzyl alcohol 40-85 0.4-1.3
MRSA 2.64 Lactic acid 10-20 O. 1-0.3
1.3 Propanediol 15-40 O.15-0.6
Example 36 Tetrhydrocurcuminoid 3-10 O.O3-0.15
0289. The present Example provides preservative compo
sitions containing BPL. Table 139 provides a summary of the
general formulation for stock Solutions and for that used in Table 140 provides the formulations for various preservative
cream product. compositions (PC).

TABLE 140

PC8 PC14 PC18 PC19 PC2O

Cream Cream Cream Cream Cream

Ingredients Stock (1.1% stock) Stock (1.3% stock) Stock (1.2% stock) Stock (1.5% stock) Stock (1.5% stock)
Benzyl alcohol 72.7 O.8 61.5 O.8 834 1.O 66.7 1.O 66.7 1.O
1.3 Propanediol 22.7 O.25 19.2 O.25 16.6 O.25 2O.O O.3
US 2012/020 1902 A1 Aug. 9, 2012
45

TABLE 140-continued
PC8 PC14 PC18 PC19 PC2O

Cream Cream Cream Cream Cream

Ingredients Stock (1.1% stock) Stock (1.3% stock) Stock (1.2% stock) Stock (1.5% stock) Stock (1.5% stock)
Tetrhydro- 4.6 O.OS 3.9 O.OS 340 O.OS
curcuminoid
Lactic acid 15.4 O.2 16.6 O.2 13.3 O.2 13.3 O.2

Method of evaluating the efficacy of preservatives. Test

Method B: Bacteria: 10 CFU organism/ml. For the test TABLE 142-continued
samples, preservative was added to 10 grams of the cream at
a concentration Of 1.5-2% and mixed well. From this sample, Pre-Op Pre-Op Pre-Op Pre-Op
1 gram al1quo
liquots were pplaced into 10 ml sterile pplastic culture Disin-
fectant- Disin-
fectant- Disin-
fectant- Disin
fectant
tubes and 0.1 ml (100 micro liters) of the test inoculums was CHG CHG-Gel PVI PVI-Ge.
added and vortexed until uniformly blended. The tubes were Ingredient % Wiw % Wiw % ww % Wiw
then placed into incubators at 37° C. for 24 hours. At the end Glycerine 4 4
of the incubation period, 9.0 ml of Butterfield Phosphate PVI 7.5 7.5
Buffered solution with neutralizer was added to the incubated Water 25.8 25.4 81.5 81.1
cultured sample and vortexed until completely mixed. The
samples were serially diluted and then plated in Trypticase
soyagar (TSA). The plates were incubated at 37°C. tempera- Example 38
ture for 24-48 hours, and the counts were read. Placebo cream
was tested similarly and used as the control. Table 141 shows 0291. The present Example provides an evaluation of syn
the efficacy of preservative compositions against S. aureus ergistic antibacterial activity of benzyl alcohol and citrus fruit
and P aeruginosa. extract in the presence of proteinaceous media.
0292 Citrus fruit extract was obtained from PL Thomas
TABLE 141 (BiosecurF440D organic citrus fruit extract concentrate). The
S. airetts Paeruginosa
following concentrations of compounds were added to S.
logio reduction logio reduction aureus culture (10 cfu/ml of media containing 50% TSB and
Groups from control from control 50% bovine serum). After 1 minute, drug neutralizing fluid
#14 7.70 7.91
(DNF) was added and mixed. The samples were then serially
#18 4.86 7.91 diluted with DNF and plated in TSA plate. The plates were
#19 7.70 7.91 incubated for 24-48 hours at 37° C. and colony counts were
#2O 7.70 7.91 determined.

TABLE 143
Example 37 Antibacterial activity against
S. Aureus (10 CFU/ml)
0290 Example 36 provides various formulations for pre Groups (% w/w) logio reduction
operative skin disinfectant compositions. These composi Citrus extract 1.0 1.61
tions contain synergistic combinations of benzyl alcohol, Citrus extract 0.5 1.O
fruit acid, and antimicrobials such as chlorhexidine glucon Benzyl alcohol 2.0 O.1
Citrus 0.5 + Lactic acid O.2 0.7
ate (CHG) or povidone iodine (PVI). Benzyl alcohol 2.0 + Citrus oil 0.5% 7.94
Benzyl alcohol 2.0 + Lactic 7.94
TABLE 142 acid O.2 + Citrus oil 0.5%

Pre-Op Pre-Op Pre-Op Pre-Op

Disin- Disin- Disin- Disin 0293. The data show that benzyl alcohol and citrus extract
fectant-
CHG
fectant-
CHG-Gel
fectant-
PVI
fectant
PVI-Ge.
exhibits significant synergism.
Ingredient % Wiw % Wiw % Wiw % Wiw
Example 39
Benzyl alcohol 3 3 3 3
Lactic acid
SDA3C
2
67.2
2
67.2
2 2 0294 The present Example provides an evaluation of
alcohol alcohol hand disinfectants in a pig skin model. In the present
CHG 2 2 Example, Purell (alcohol-based hand sanitizer (Gojo) was
Polyduaternium O.2 O.2 evaluated. Additionally, a second Purell formulation was
10
Hydroxypropyl O.2 O.2
evaluated, Purell--(purell hand sanitizer+2% benzyl alcohol--
methyl cellulose 3% Zemea+2% lactic acid).
(K4M) 0295 The Example measured rapid and sustained activity
1.3 propanediol 2 2 using pigskin method which simulates ASTM E1174 test for
hand disinfectant. Two skin pairs were rinsed and washed
US 2012/020 1902 A1 Aug. 9, 2012
46

with antibacterial soap 30 seconds. One piece of the pair was Example 41
contaminated with 30 ul of a 107 cfu bacterial culture, the 0299 The present Example provides an evaluation of
two pieces were rubbed for 30 seconds and allowed to air dry
for 30 seconds. The bacteria was eluted with PBS and plated nutraceutical and food antibacterial (NFA) compositions. The
after serial dilution. These counts were used as baseline following table provides the details of NFA preservative com
COuntS. position #1.
0296 To evaluate the efficacy of test solutions, the same TABLE 1.47
pair of skin pieces was rinsed and washed using non-antibac
terial soap and recontaminated as above. After the 30 second Composition of Concetration range
drying period 0.5 ml of the antibacterial soap being tested was Ingredients stock solution in use level
placed on the skin and rubbed together. The rest of the pro Benzyl alcohol 8O 0.4-1.6
cedure was followed as described above for the baseline Citrus extract 1O.O O.OS-O2
counts except that Drug neutralizing fluid was used for the Grapefruit seed extract 1O.O O.OS-O2
test as the sampling fluid.
0297 Bacterial contamination and application of test The use level is in 50-200 fold dilution of stock in water.
solutions were repeated (total of 5 application), only differ
ence in the method is after the application of test solution the (0300. The antibacterial activity of NFA 1 (1 to 100 dilu
skins were left at room temperature for drying for 5 minutes tion) was evaluated. 100 ul of S. aureus (10 cfu/ml) was
before recontamination. After the fifth application and drying added to 1 ml of the diluted preservative and left at room
for 5 minutes pigskins were rinsed with Drug neutralizing temperature for 1 minute. Another set was left at room tem
fluid to elute the remaining bacteria. Table 144 provides the perature for 5 minutes. Drug neutralizing fluid was added to
results from rapid and Sustained activity using pigskin the samples after appropriate time and serially diluted. Ali
method using the test organism S. aureus. quots were plated on Trypticase Soyagar plate and incubated
at 37° C. for 24-48 hours. For control, PBS was used instead
TABLE 1.44 of the preservative and processed similarly.
After first application After 5" application TABLE 1.48
Log10 reduction from control Log10 reduction from control
growth growth logo reduction from
Time control growth
Purell 18O 0.55
Purell- 2.75 2.50 1 minute 5.3
5 minute 5.3

Required logo reduction for rapid and Sustained activity by

the ASTM E1174 test is 2.0 logo for rapid and 3.0 logo for Example 42
sustained activity. In conclusion, the addition of BPL to Purell
enhances the activity especially the Sustained activity signifi 0301 The present Example provides various formulations
cantly.
for coSmaceutical preservative compositions containing ben
Zyl alcohol and citrus extract.
Example 40
TABLE 149A
0298. The present Example provides formulations for
exemplary, but not limiting, preservative compositions of the Formulation 14A
present invention. Amount in cream
Ingredients Stock (%) containing 1.3% stock
TABLE 145
Benzyl alcohol 61.54 O.8
Preservative Composition 21A Citrus extract (BS440D) 15.38 O.2
Tetrahydrocurcuminoid 3.85 O.OS
Composition of Cream containing (THC)
Ingredients stock solution 1.0% stock 1,3-propanediol 19.23 O.25
Use level is 1.0-2.0%
Benzyl alcohol 8O O.8
Citrus extract 2O O.2

TABLE 149B
TABLE 1.46 Formulation 14B

Preservative Composition 21B Amount in cream

Ingredients Stock (%) containing 1.35% stock
Composition of Cream containing
Ingredients stock solution 12% stock Benzyl alcohol 37.0 O.S
Citrus extract (BS440D) 22.3 O.3
Benzyl alcohol 66.7 O.8 Tetrahydrocurcuminoid 3.70 O.OS
Citrus extract 16.7 O.2 (THC)
Grapefruit seed extract 16.7 O.2 1,3-propanediol 37.0 O.S
US 2012/020 1902 A1 Aug. 9, 2012
47

TABLe 149C TABLE 152-continued

Formulation 14C Ingredients OCP8% (w/w) Lysterine
Amount in cream Sodium saccharin O.08 NA
Ingredients Stock (%) containing 1.55% stock Pluronic F127 O.3 NA
Zinc salicylate O.OS
Benzyl alcohol 32.2 O.S Copper salicylate O.O2S
Citrus extract (BS44OD) 19.4 O.3 Thymol O.064 O.064
Tetrahydrocurcuminoid 3.20 O.OS
Menthol O.04 O.04
(THC) Eucalyptol O.O92 O.O92
1,3-propanediol 32.3 O.S
Lactic acid 12.9 O.2 Methyl salicylate O.O6 O.O6
Use level is 1.2-2.0% Benzyl alcohol 1.O
Lactic acid O.2
Sorbitol solution O.1 NA
Benzoic acid O.1 NA
Example 43 Sodium benzoate O.OS NA
Ethanol 10.6 21.6
0302) The present Example provides a formulation and Citrus extract C-320C O.S
evaluation of neutraceutical and food preservative (NP) com
positions. Specifically, this formulation contains benzyl alco
hol and citrus extract. 0305 An evaluation of the rapid killing efficacy of oral
care products was carried out. 0.8 ml of OCP8 and Lysterine
TABLE 150 mouth wash was added to 0.1 ml of 108 cfu/ml of bacteria
NPA Stock (%) (MRSA) and 0.1 ml of Bovine serum After vortexing for 15
Benzyl alcohol 8O
seconds, 9 ml of drug neutralizing fluid (DNF) was added and
Citirus extract 2O mixed. The samples were then serially diluted with DNF and
plated in TSA plates. The plates were incubated for 24 hours
NPB Stock (%) at 37° C. and colony counts were determined. The following
Benzyl alcohol 8O table provides the results for the rapid antibacterial (15 sec
Citrus extract 10 onds) activity of the mouthrinse OCP8 against the test organ
Grapefruit seed extract 10 ism MRSA.
Use Level is 1-2%

TABLE 153
0303. The method used for the evaluation of the efficacy of
the NP compositions includes the following. 1 ml of NPblend Group
logo reduction from
control growth
was added to S. aureus culture (0.1 ml of 106 cfu/ml). After
Vortexing the blend for 1 minute, drug neutralizing fluid OCP8 3.63
(DNF) was added and mixed. The blends were then serially Lysterine 2.7
diluted with DNF and plated in TSA plates. The plates were
incubated for 24-48 hours at 37° C. and colony counts were
determined. The following Table provides the results. Example 45
TABLE 1.51
0306 The present Example provides a formulation and
log in reduction from control growth evaluation of an aqueous hand Santifizer containing benzyl
Organism NPA NPB alcohol and botanicals. The following table provides 3 non
limiting examples of formulations.
S. airetts 5.3 4.9
MRSA 4.24 (Not Done) TABLE 154
E. coi S.6 S.O
18LA8 37D 32

Phase A
Example 44
Grapefruit seed 1.O O O
0304. The present Example provides a formulation for an extract
oral care composition containing benzyl alcohol and citrus Citrus extract O O.S O
extract. The following Table provides the details of the test (Biosecure F44OD)
Benzethonium O O O.2
compositions (OCP8) with Lysterine. chloride
Benzyl alcohol 2 2 2
TABLE 152 1.3 Propanediol 3 3 3
Lactic acid 2.O 2.0 O
Ingredients OCP8% (w/w) Lysterine Citric acid O O 2.0
Glucopon 215UP 1 1 1
Water 76.739 NA SDA3C 10 10 O
Glycerin 1O.O NA SDA 4OB O O 10
US 2012/020 1902 A1 Aug. 9, 2012
48

Example 46
TABLE 154-continued
0310. The present example is directed to the preparation of
18LA8 37D 32 hydrophilic creams.
Phase B
0311. The following formulation is a placebo cream with
out wound healing agents and antimicrobial agents.
Water 80.1 80.6 80.8
HPMC (K4M) O.2 O.2 O.2 TABLE 1.57
Polyguaternium10 O.2 O.2 O.2
1.3 Propanediol O.S O.S O.S Hydrophilic cream base (Placebo cream
Zinc lactate O O O.1
pH 3.3-3.6 Ingredient % (w.fw)
Petrolatum 8.0
Stearyl alcohol 12.0
0307. The following Table provides the data for in vitro Isopropyl Myristate 4.0
rapid kill (15 seconds) using the FDATEM method (Method Sorbitan oleate 2.0
A described above). Polyoxy 40 stearate (Myri 52) S.O
Germal + O.3
TABLE 155 Propylene glycol 4.0
Water 64.7
logia reduction from control growth
Organism 37D 18LA-8 32 Purell The following formulation is a wound healing cream contain
ing Zinc salts and calendula oil (W-ZC cream).
E. Coi 7.8O 7.06 8.O 6.39
MRSA 7.25 8.O2 7.25 8.1 TABLE 158
S. airetts 8.8 8.14 8.14 8.64
Paeruginosa 7.3 8.1 8.2 7.56 W-ZC cream
K. pneumonia 4.5 4.6 4.5 4.0
Ingredient % (w.fw)
Petrolatum 8.0
0308 Method B. Rapid and sustained activity using pig Stearyl alcohol 12.0
skin method which simulates the ASTM E1174 test for hand Isopropyl Myristate 4.0
disinfectants. Two skin pairs were rinsed and washed with Sorbitan oleate 2.O
antibacterial soap for 30 seconds. One piece of the pair was Polyoxy 40 stearate (Myri 52) S.O
Germal + O.3
contaminated with 30 ul of a 107-cfu bacterial culture. The Propylene glycol 4.0
two pieces were rubbed for 30 seconds and allowed to air dry Zinc Lactate O.2
for 30 seconds. The bacteria was eluted with PBS and plated Zinc Oxide O.3
after serial dilution. These counts were used as baseline Calendula oil 1.O
Water 63.2
counts. To evaluate the efficacy of test solutions, the same pair
of skin pieces were recontaminated as above. After the 30
second drying period, 0.5 ml of the antibacterial product 0312 The following formulation is an antimicrobial
being tested was placed on the skin and rubbed together. The cream containing silver Sulfadiazine (AgSD cream).
rest of the procedure was followed as described above for the
baseline counts except that drug neutralizing fluid was used TABLE 1.59
for the test as the sampling fluid. Bacterial contamination and
application of test solutions were repeated (total of 5 appli AgSD cream
cations). The only difference in the method is after the appli
cation of test Solution, the skins were left at room temperature Ingredient % (w.fw)
for drying for 5 minutes before recontamination. After the Petrolatum 8.0
fifth application and drying for 5 minutes, pigskins were Stearyl alcohol 12.0
rinsed with drug neutralizing fluid to elute the remaining Isopropyl Myristate 4.0
bacteria. Sorbitan oleate 2.0
Polyoxy 40 stearate (Myri 52) S.O
0309 The following Table provides the data for rapid and Germal + O.3
Sustained activity using pigskin method (stimulates ASTEM Propylene glycol 4.0
E1174 test for hand disinfectant) against the organism S. Silver sulfadiazine 1.O
aureus. The required logo reduction for rapid and Sustained Water 63.7
activity by the ASTM E1174 test is 2.0 logo for rapid and 3.0
logo for Sustained activity. 0313 The following formulation is an antimicrobial and
TABLE 1.56
wound healing cream containing silver Sulfadiazine, Zinc
salts, and calendula oil (AgSD-ZC).
After first application After 6th application
Log10 reduction Log10 reduction TABLE 160
from control from control
Composition group group AgSD-ZC cream
37D 2.3 4.5 Ingredient % (w.fw)
18 LA-8 2.96 3.67
Purell 1.8 0.55 Petrolatum 8.0
Stearyl alcohol 12.0
US 2012/020 1902 A1 Aug. 9, 2012
49

Example 47
TABLE 160-continued
0316 The present example determines the antibacterial
AgSD-ZC cream activity of topical creams for the treatment of surface wounds.
Ingredient % (w.fw) 0317 Zone of inhibition test. Trypticase soy agar plates
were seeded with 0.1 ml of 108 cfu of various bacteria and
Isopropyl Myristate 4.0 107 cfu of C. albicans. Four wells of 0.7 cm diameter were
Sorbitan oleate 2.O
Polyoxy 40 stearate (Myri 52) S.O made on the plate using cork borer. Each well was filled with
Germal + O.3 0.1 gm of the cream, and the plates were incubated for 24 hors
Propylene glycol 4.0 at 37°C. The Zones of inhibition were measured.
Zinc Lactate O.2
Zinc Oxide O.3
Calendula oil 1.O TABLE 163
Silver Sulfadiazine 1.O
Water 62.2 Zones of Inhibition (mm) of creams

Organisms AgSD- AgSD- AgSD

Gram Positive Z. ZC AgSD ZC ZC-1 ZC-2
0314. The following formulation is a cream containing
silver Sulfadiazine, Zinc salts, calendula oil, and a silver S. airetts- 8.0 9 15.5 16.0 25 25
releasing agent and Stabilizer (AgSD-ZC-1 cream). Specifi MRSA 11 12 14 14 33 34
Paeruginosa 10 19 15 16 19.5 2O
cally, the cream contains lactic acid as the silver releasing C. albicans 8 8 16 17 18 19
agent and Sodium perborate as the stabilizer.
Conclusion: Creams containing silver releasing agent, stabilizer (AgSD-ZC 1) and the same
+ octanediol (AgSD ZC2) show higher zones of inhibition.
TABLE 161
AgSD-ZC-a Crean Example 48
Ingredient % (w.fw)
0318. The present example provides an evaluation of vari
Petrolatum
Stearyl alcohol
8.0
12.0
ous creams on their efficacy in reducing bacterial growth on
Isopropyl Myristate 4.0 infected burn wounds.
Sorbitan oleate 2.O 0319 Pig Skin Method. Pig skin was washed and steril
Polyoxy 40 stearate (Myri 52) S.O ized by soaking in 70% ethanol for 15 minutes. Several 1.5
Germal + O.3
Propylene glycol 4.0 cm pieces were cut and rinsed in sterile saline. A circular
Zinc Lactate O.2 cylinder (1 cm diameter) was heated on a Bunsen burner for
Zinc Oxide O.3 10 seconds by keeping and pressing for 10 seconds on the
Calendula oil 1.O dorsal side of the skin. After 10 minutes, the burned surface
Silver sulfadiazine 1.O
Lactic acid 1.O was inoculated with 10 ul of 108 cfu/ml of the test organism
Sodium perborate 1.O and incubate at 37° C. for 1 hour. 0.1 gm of various creams
Water 60.2 were applied on each of the infected skin, spread evenly, then
incubated for 2 hours at 37°C. (3 skin samples were used for
each group). Then, the cream was removed by wiping with
0315. The following formulation is a cream containing sterile wet gauze. The 3 samples of skin were transferred to a
silver Sulfadiazine, Zinc salts, calendula oil, lactic acid as a sterile tube containing 30 ml sterile saline (3 skins from 1
silver releasing agent, Sodium perborate as a stabilizer, and group/30 ml). The samples were vortexed for 10 seconds, and
octanediol as an antifungal activity enhancing agent (AgSD the skins were removed to fresh Saline and the rinsing process
ZC-2 cream). repeated. The skins were removed and blotted dry on a sterile
guaze. Each skin was transferred to a culture tube containing
TABLE 162 4.0 ml drug inactivating media, Sonicated for 20 minutes to
remove the adherent bacteria from the skin to the media. 0.5
AgSD-ZC-2 cream
ml of the media was plated on trypticase Soyagar. The plates
Ingredient % (w.fw) were then incubated for 24-48 hours and the colony counts
were determined
Petrolatum 8.0
Stearyl alcohol 12.0
Isopropyl Myristate 4.0 TABLE 164
Sorbitan oleate 2.O
Polyoxy 40 stearate (Myri 52) S.O Reduction of bacterial counts in Pig Skin
Germal + O.3 Log10 reduction from control cream
Propylene glycol 4.0
Zinc Lactate O.2 Group Satiretts Paeruginosa C. albicans
Zinc Oxide O.3
Calendula oil 1.O AgSD O.2 1.1 O.32
Silver sulfadiazine 1.O AgSD-ZC 1.2 1.1 0.4
Lactic acid 1.O AgSD-ZC-1 3.0 3.9 O.S9
Sodium perborate 1.O AgSD-ZC-2 3.5 4.2 1.32
12 Octanediol O.S
Water 59.7 Conclusion: Creams containing silver releasing agent, stabilizer (AgSD-ZC 1) and the same
+ octanediol (AgSD ZC 2) show higher efficacy. The cream containing Octanediol show
higher antifungal activity,
US 2012/020 1902 A1 Aug. 9, 2012
50

Example 49
TABLE 167-continued
0320. The present example is directed to a topical anti
inflammatory/wound healing/antimicrobial composition Silvadex 1
containing silver Sulfadiazine, Synergistic combinations of Ingredient % (w.fw)
benzyl alcohol, curcumin, 1.3 propanediol, calendula oil and
Zinc salts for the treatment of burn wound and other surface Calendula oil 1.O
wound infections. Silversulfadiazine 1.O
Lactic acid O.O6
0321. In order to develop a broad spectrum antimicrobial, Water 55.63
anti-inflammatory topical cream with wound healing proper
ties for control ofburn and other surface wound infections, a
cream containing silver Sulfadiazine, and the Synergistic 0324. The following cream contains silver sulfadiazine,
combination of benzyl alcohol, tetrahydroxy curcuminoids Zinc salts, calendula oil and BTCP (Silvadex 2).
(THC), 1.3 propanediol (BTCP), calendula oil and zinc salts
was developed. The pH was adjusted to 6.3-6.4. Placebo TABLE 168
cream A (below) is a cream without wound healing agents and Silvadex 2
antimicrobial agents
Ingredient % (w.fw)
TABLE 1.65
Petrolatum 9.68
Placebo cream A Stearyl alcohol 14.52
Isopropyl Myristate 4.84
Sorbitan oleate 2.42
Ingredient % (w.fw) Polyoxy 40 stearate (Myri 52) 6.OS
Petrolatum 9.68 Germal + O.3
Stearyl alcohol 14.52 Propylene glycol 4.0
Isopropyl Myristate 4.84 Zinc Lactate O.2
Sorbitan oleate 2.42 Zinc Oxide O.3
Polyoxy 40 stearate (Myri 52) 6.OS Calendula oil 1.O
Germal + O.3 Silversulfadiazine 1.O
Propylene glycol 4.0 Benzyl alcohol O.S
Water S8.19 THC 0.075
1.3 propanediol O.S
Lactic acid O.O6
Water 54.56
0322 The following formulation is a cream containing
silver sulfadiazine (AgSD-A).
0325 The followingTable provides the Zones of inhibition
TABLE 166 (mm) of creams against C. albicans.
AgSD-A cream TABLE 169
Ingredient % (w.fw)
Calbicans
Petrolatum 9.68
Stearyl alcohol 14.52 Silvadex 1 2O
Isopropyl Myristate 4.84 Silvadex 2 25
Sorbitan oleate 2.42 AgSD ZC-2 19
Polyoxy 40 stearate (Myri 52) 6.OS Commercial SSD 16
Germal + O.3 (Kendall)
Propylene glycol 4.0
Sillyersulfadiazine 1.O Conclusion: Silvadex creams containing BTCP are more effective than that containing
Octanediol.
Water 57.19

Example 50
0323. The following cream contains silversulfadiazine,
one insoluble Zinc salt and one soluble Zinc salt, and calen 0326. The present example is directed to wound healing
dula oil (Silvadex 1). and infection control in burned rats treated with various
CCS.
TABLE 167 0327 36 Rats were deeply anesthetized using ketamine
Silvadex 1
Xylazine mixture injection given intramuscularly (50 mg/kg
each). A brass bar (20x20x100 mm) was heated in boiling
Ingredient % (w.fw) water for 15 minutes and the end of the heated bar was applied
on the shaved back of the rats for 45 seconds. The wound area
Petrolatum 9.68 was measured.
Stearyl alcohol 14.52
Isopropyl Myristate 4.84 0328. After a period of 30 minutes, freshly prepared bac
Sorbitan oleate 2.42 terial inoculums of Pseudomonas aeruginosa (MTCC 741)
Polyoxy 40 stearate (Myri 52)
Germal +
6.OS
O.3
containing 10 cfu per ml was applied topically on the site of
Propylene glycol 4.0 burn wound area at the dose rate of 2000 per rat. Infection was
Zinc Lactate O.2 done only once.
Zinc Oxide O.3 0329. All of the animals were divided in different groups
of 9 animals in each group and given various treatment 4
US 2012/020 1902 A1 Aug. 9, 2012

hours after infection. About 1 gm of cream was applied topi

cally in each rat wound twice daily for 12 days. TABLE 172
0330. Each day before applying the new cream, the old Efficacy of Disinfectant cleanser
cream residue was removed by gently rubbing the burn
wound area with sterile saline gauze. Group Bacterial Growth (Log10) Log reduction
0331. On day 12 after the induction of burn wound/bacte Group I (control) 5.3
rial infection, the burn wound eschar was removed Surgically. FDC-1
VF wash
2.3
S.1
3.0
O.2
The burn wound area was measured. Animals were sacrificed
at the termination of the experiment.
0332. After the wound eschar was removed, Swab samples 0335 Various patent and non-patent publications are cited
were taken from the center of the burn wound area from all 36 herein, the contents of which are hereby incorporated by
reference in their entireties.
rats (from all four treatment groups), and a semi quantitative
bacterial assay was performed by spreading the Swab culture 1-22. (canceled)
from each rat on a nutrient agar plate, and incubating the 23. An antifungal topical cream comprising a synergistic
plates at 37°C. for 24 hrs. The bacterial growth on the plates combination of 0.5-5% w/w benzyl alcohol and one or more
was determined. of compounds selected from the group consisting of
0333. The following table provides the percentage of (a) 0.3-5.0% w/w 1.3 propanediol and its derivatives,
reduction of wound area and bacterial counts in wound area of (b) 0.04-0.5% w/w botanicals selected from the group con
rats burned and treated with various creams. sisting of curcumin compounds,
(c) 0.04-1.05% w/w essential oils, fruit extracts, and plant
TABLE 170 eXtracts,
(d) 0.2-2.0% w/w fruit acid, and
Wound area (mm) of animals on day 1 and day 12 (e) 0.5-2.0% alkanediols.
% Reduction in
24. (canceled)
wound area from Bacterial counts 25. An antimicrobial composition comprising:
Group Treatment day 1 to day 12 on day 12 (a) from about 0.5% to about 10% (w/w) benzyl alcohol or
1 Placebo Cream 16.86 7.5 x 10
its derivatives; and
Commercial 9.09 2.5 x 10 (b) from about 0.2 to about 4.0% (w.fw) botanical extracts:
silversulfadiazene wherein the combination of benzyl alcohol and botanical
3
4
AgSD-A cream
Silvadex 1
18.47
27.97
3.03 x 10?
1.6 x 10'
extract exhibits synergistic activity.
26-31. (canceled)
32. The antimicrobial composition of claim 25, wherein
the botanical extract is selected from the group consisting of
Example 51 grapefruit seed extract, grapefruit peel extract, pomegranate
seed extract, citrus extract, oregano extract, thyme extract,
0334. The present example is directed to the efficacy of resveratrol, curcumin compounds, green tea extract, white tea
NP-CG1 on contaminated meat. 1 cm samples of pig flesh extract, soy extract, fermented soy protein, aloe Vera extract,
with skin were contaminated with E. coli by soaking them in and aloe Vera juice.
E. Coli culture (104 cfu/ml) for 4 hours. The skin/flesh were 33-38. (canceled)
removed and blotted dry and divided into 3 groups of 4 pieces 39. An antimicrobial composition comprising a synergistic
per group. Each group was soaked for 5 minutes in solution, combination of:
removed and rinsed with saline. The Solution contained saline (a) from about 2% to about 10% (w/w) benzyl alcohol and
rinse (group 1), FDC-1 rinse (group 2), or commercial veg its derivatives;
etable fruit wash (VF wash) (group 3). The formulation for (b) from about 2% to about 4% (w/w) fruit acids:
the FDC-1 rinse is provided below. (c) from about 0% to about 10% (w/w) 1.3 propanediol;
(d) from about 0% to about 4% (w/w) botanical extracts;
TABLE 171 (e) from about 0% to about 1% (w/w) essential oil; and
FDC-1 % Wiw
(f) from about 0% to about 5% (w/w) synthetic antimicro
bials.
Benzyl alcohol 2.O 40. A disinfectant products comprising the antimicrobial
Citric acid
Citrus extract
1.O
O.2
composition according to 39.
Glucopon 215 UP 2.O 41. (canceled)
Water 94.8 42. An alcohol based skin disinfectant comprising:
pH 3.5 (a) from about 5% to about 70% (w/w) analiphatic alcohol:
Use undiluted
(b) from about 1% to about 5% (w/w) benzyl alcohol
(c) from about 0.2% to about 4% monocarboxylic fruit
Each piece was then transferred to a culture tube and 5 ml acid;
drug neutralizing fluid (DNF) was added and sonicated for 20 (d) from about 0% to about 10% alkanediol;
minutes to remove the adherent bacteria to the fluid. After (e) from about 0% to about 2% synthetic antibacterial
serial dilution, the samples were plated on Tripticase Soyagar agent (0-2%); and
and incubated for 24 hours. The following Table provides the (f) from about 20% to about 90% water.
levels of bacterial growth amongst the groups. 41. (canceled)
US 2012/020 1902 A1 Aug. 9, 2012
52

44. A topical composition comprising synergistically 50. The topical composition of claim 44, further compris
effective amounts of: ing a fruit acid.
(a) a silver compound; 51. The topical composition of claim 49, wherein the fruit
(b) an essential oil or individual constituent; and acid is selected from the group consisting of citric acid, lactic
(c) one or more Zinc salts. acid, and mixtures thereof.
45. The topical composition of claim 44, wherein the silver
compound is silver SulfadiaZene. 52. The topical composition of claim 44, wherein the zinc
46. The topical composition of claim 44, wherein the salts comprise a soluble Zinc salt and a nonsoluble Zinc salt.
essential oil or individual constituent is selected from the 53. (canceled)
group consisting of calendula oil, curcuminoids, and mix 54. The topical composition of claim 48, further compris
tures thereof.
47. The topical composition of claim 44, further compris ing benzyl alcohol.
ing one or more additional antimicrobial agents. 55. A food disinfectant cleanser comprising from about 0.5
48. The topical composition of claim 44, further compris to about 5.0% benzyl alcohol, from about 0.2 to about 2.0%
ing one or more alkanediol. fruit acid, from about 0.2 to about 1.0% botanical extract,
49. The topical composition of claim 48, wherein the from about 0.1 to about 5.0% surfactant, and water.
alkanediol is selected from the group consisting of 1.3 pro c c c c c
panediol, octanediol, decanediol, and mixtures thereof.