WO2008061375A1

WO2008061375A1 - Antiseptic

Info

Publication number: WO2008061375A1
Application number: PCT/CA2007/002121
Authority: WO
Inventors: George Botos
Original assignee: Germiphene Corporation
Priority date: 2006-11-24
Filing date: 2007-11-23
Publication date: 2008-05-29

Abstract

The present invention provides an antiseptic comprising a mixture of a one to four carbon alkyl alcohol and lactic acid as an antimicrobial agent, and a solvent. The antiseptic may further comprise at least one of a thickener, a surfactant, and an emollient. The antiseptic may be in the form of a sanitizing gel, a liquid, a spray, or a foaming liquid, and may be used as an antimicrobial skin cleaner or hand sanitizer.

Description

An Antiseptic Comprising a Mixture of C_M Alkyl Alcohol and Lactic Acid in a Solvent

FIELD OF THE INVENTION

[0001] This invention relates to an antiseptic and more specifically to an antiseptic comprising lactic acid and alcohol, intended for infection control.

BACKGROUND OF THE INVENTION

[0002] Alcohol is the most widely used skin antiseptic agent. Antiseptics are often used for infection control in high risk areas such as hospitals, and for aseptically treating a certain skin area prior to surgical intervention, injections, or examination of body cavities.

[0003] Most of the hand sanitizers and other skin antiseptics currently on the market for medical use are ethanol-based or have ethanol as one of the active ingredients. In addition to alcohol, such antiseptics may contain other antimicrobial agents, such as quaternary ammonium compounds, and skin care components to reduce or prevent the severe drying of the skin observed following prolonged used of alcohol-based skin antiseptics.

[0004] Currently, there are a number of antiseptics on the market, using different delivery forms such as spray, gels and foams, and having alcohol content between 60% and 80% w/w ethanol. This high level of alcohol is used to achieve the level of effectiveness required within a very short contact time. However, one problem with repeatedly using an antiseptic product with high alcohol content is severe drying of the skin.

[0005] To prevent skin drying, a number of solutions have been proposed. U.S. Patent No. 5,591,442 proposes the use of a mixture of 25% to 40% alcohol with a glycerol monoalkyl ether. This composition has a lower impact on skin due to its lower alcohol content.

[0006] U.S. Patent No. Patent 5,492,932 proposes the use of a cetyl alcohol and a glycolic acid in an isopropanol solution to act as a barrier that will prevent skin from drying.

[0007] U.S. Patent Applications Nos. 2006/010499 and 2005/0129626 propose the use of a foaming alcohol composition, having an alcohol content of 60% to 80%. The advantage presented is that foam application will reduce the amount of product applied on the skin, thus limiting the drying effect.

[0008] U.S. Patent Application No. 2005/0019355 proposes the use of lactic acid esters at between 2% and 50% of the composition as the antimicrobial agent. This product has the advantage that the esters of lactic acid are know for their emollient properties.

SUMMARY OF THE INVENTION

[0009] According to one broad aspect of the invention, there is provided an antiseptic, comprising as an antimicrobial agent a mixture of a one to four carbon alcohol and at least one of lactic acid and a lactic acid salt, and a solvent.

[0010] Other embodiments of the invention may further comprise at least one of an additional antimicrobial agent, a thickener, a surfactant, a neutralizer, and an emollient. The antiseptic may be used in a hand sanitizer or an antimicrobial skin cleanser.

[0011] An advantage of certain embodiments of the antiseptic of the present invention is that there is very limited skin drying due to the presence of the lactic acid, which acts as a moisturising agent.

[0012] A further advantage of certain embodiments of the antiseptic of the present invention is that the antiseptic achieves similar antimicrobial properties as current alcohol-based skin antiseptics, but using lower alcohol content in a synergistic combination with lactic acid.

[0013] A further advantage of certain embodiments of the antiseptic of the present invention is that the antiseptic provides a residual bacteriostatic effect after the alcohol evaporation.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] In the following description, numerous specific details are set forth to provide a thorough understanding of the invention. However, it is understood that the invention may be practiced without certain specific details. [0015] Described here is an antiseptic that has a low concentration of alcohol. The antiseptic can use different delivery forms, such as gels, sprays or foaming liquids. The antiseptic is useful for use in hospital settings, medical or dental offices, or other areas that present a high risk of contamination or spreading infections. The antiseptic is also useful for local skin antisepsis for small surgical procedure, injections, and examination of body cavities. Another use of the antiseptic is as a general skin cleanser or specifically for wounds, cuts, minor burns and insect bites.

[0016] According to a broad aspect of the invention, the antiseptic comprises a mixture of a one to four carbon alkyl alcohol and lactic acid or a lactic acid salt as an antimicrobial agent, and a solvent. The antiseptic may also comprise at least one of a surfactant, a thickener and an emollient. In the absence of a specific mention of the solvent in the compositions described herein, the remainder of the composition, typically expressed as %w/w, is made up of the solvent. The solvent is preferably water.

[0017] The antiseptic can be presented under different delivery forms such as a gel, a solution, a foaming liquid, or a spray.

[0018] Additional antimicrobial agents, such as quaternary ammonium compounds, triclosan, hydrogen peroxide, hydrogen peroxide-generating compounds, and mixtures thereof may be added to further increase the bactericidal, fungicidal and virucidal properties of the antiseptic. However, it will be understood by a person skilled in the art that any additional antimicrobial agent may be used that would be suitable for application to the skin.

[0019] One advantage of the proposed composition is in achieving similar antimicrobial properties as current alcohol-based skin antiseptics, but using lower alcohol content in a synergistic combination with lactic acid, while ensuring a residual bacteriostatic effect. Moreover, lactic acid acts as a moisturizing agent, reducing even further the drying effect of the alcohol.

[0020] In one embodiment of the invention, the one to four carbon alkyl alcohol, preferably ethanol, is present at less than 50% w/w, more preferably at 5.0% to 50% w/w, further preferably at 20% to 40% w/w, even further preferably at 30% w/w. [0021] In another embodiment of the invention, lactic acid or a lactic acid salt is preferably present at 0.1% to 10% w/w, more preferably at 0.5% to 5% w/w, further preferably at 3.0% w/w.

[0022] In some embodiments of the antiseptic, a thickener is also present to produce a gel. The thickener may be at least one of polyacrylate, a polyacrylic polymer, a cellulose derivative, and mixtures thereof. The cellulose derivative may be at least one of hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropylmethyl cellulose, xantham gum, and mixtures thereof. The thickener, preferably hydroxyethyl cellulose (HEC), is present at 0.1% to 5.0% w/w, more preferably at 0.5% to 3.0%, further preferably at 1.0% w/w.

[0023] In some embodiments of the antiseptic, a surfactant is also present to produce stable foam upon dispensing through a foaming dispenser. The surfactant may be at least one of an ethoxylated alcohol, sodium laureth sulphate, sodium lauryl sulphate, an alkyl betaine, an alkyl polyglycoside, and mixtures thereof, or any similar cosmetic grade surfactant. Preferably, the surfactant is a mixture of an alkyl polyglycoside (APG) and sodium lauryl sulphate. Preferably, APG is present at 0.1% to 5.0% w/w, more preferably at 1% to 3.0% w/w, further preferably at 1.66% w/w. Preferably, sodium lauryl sulphate is present at 0.1% to 5.0% w/w, more preferably at 0.5% to 3.0% w/w, further preferably at 1.0% w/w.

[0024] In some embodiments of the antiseptic, a neutralizer is also present to adjust the pH of the antiseptic. The neutralizer may be selected from sodium hydroxide, potassium hydroxide, triethanolamine, and mixtures thereof. The neutralizer, preferably sodium hydroxide, is present at 0.1% to 2.0 % w/w, further preferably at 0.6% w/w.

[0025] Other additives may be present, such as fragrances, colouring, or emollients. Possible emollients include chamomile extract, aloe vera extract, and mixtures thereof. Preferably, the emollient is chamomile extract, which is preferably present at 0.05% w/w. Preferably, the fragrance is present at 0.1 % w/w.

[0026] In a preferred embodiment of the invention, the antiseptic comprises (w/w): ethanol at 30%, lactic acid at about 3%, sodium hydroxide at 0.6%, hydroxyl ethyl cellulose at 1.0%, chamomile extract at 0.05%, and water as a solvent making up the balance. [0027] In a particularly preferred embodiment of the invention, the antiseptic comprises (w/w): ethanol at 30%, lactic acid at about 3%, sodium hydroxide at 0.6%, sodium lauryl sulphate at 1.0%, alkyl polyglycoside at 1.66 %, chamomile extract at 0.05%, and water as a solvent making up the balance.

TEST DATA

[0028] An embodiment of the antiseptic was prepared and tested in a Time Kill Test Assay for Antimicrobial Agents, in order to determine its effectiveness. Specifically, this testing provides information on rate-of-kill of the antiseptic against single selected microorganisms. Details of the test procedure and results are provided below.

[0029] The embodiment tested was a foam formulation in a ready to use dilution, the formulation comprising (w/w) ethanol at 30%, lactic acid at about 3%, sodium hydroxide at 0.6%, sodium lauryl sulphate at 1.0%, alkyl polyglycoside at 1.66%, chamomile extract at 0.05%, and water as a solvent making up the balance. This antiseptic was against test organisms listed and prepared as detailed in Table 1.

Table 1 : Test Organisms

Blood Agar = Tryptic Soy Agar containing 5% Sterile Sheep Blood The microorganisms used in this study were obtained from the American Type Culture Collection, Manassas, Virginia.

Recovery Media

Neutralizer: Letheen Broth with 0.14% Lecithin and 1.0% Tween 80

Agar Plate Medium: Tryptic Soy Agar with 5% Sheep Blood (BAP)

Reagents

Organic Soil Load Description: 5% fetal bovine serum (FBS)

[0030] The organisms were exposed to the antiseptic for time periods of 30 seconds, 1 minute, 3 minutes and 5 minutes at ambient temperature (25⁰C and 21 °C on the days tested). The organic soil load was 5% fetal bovine serum (FBS).

Preparation of Antiseptic

[0031] The antiseptic was a ready to use (RTU) dilution. The antiseptic was homogenous as determined by visual observation at the time of test. A 9.9 mL aliquot of the antiseptic was transferred to individual sterile 25 x 150 mm Morton Closure tubes for use in testing.

Preparation of Inocula

[0032] Using a stock culture of each test organism, the culture was streaked onto a BAP plate and incubated for 24-48 hours at 35-37°C with the exception of Streptococcus pneumoniae and Streptococcus pyo genes which were incubated for 2-4 days at 35-37⁰C with 5-7% CO₂. On the day of testing, a sufficient amount of each 48 hour culture from the BAP plate was added to Butterfield's Buffer to yield turbidity equal to 0.5 McFarland Standard.

[0033] Antimicrobial susceptibility testing was performed for Methicillin Resistant Staphylococcus aureus and Vancomycin Resistant Enterococcus faecalis using representative cultures from the day of test to verify the antimicrobial resistance pattern stated. [0034] Vancomycin Resistant Enterococcus faecalis and Methicillin Resistant Staphylococcus aureus were verified to be resistant by performing a Kirby Bauer Susceptibility assay on the day of testing. The organisms were subcultured onto a BAP plate and were incubated for approximately 24 hours at 35-37⁰C. Following incubation, a suspension of each test organism equal to a 0.5 McFarland Standard was made in 0.85% sterile saline. The suspensions were streaked onto Mueller Hinton agar. An antibiotic disc was placed in the center of the inoculated Mueller Hinton plate (oxacillin was used for MRSA and vancomycin was used for VRE). The plates were inverted and incubated for S_!4 hours at 35- 37°C. Following incubation, the zone of inhibitions were measured using a calibrated caliper. A control organism, Staphylococcus aureus (ATCC 25923), was run concurrently with the test organisms using both oxacillin and vancomycin to confirm the validity of the assays. The interpretations of the zone of inhibitions are based on established performance standards of the Clinical and Laboratory Standards Institute (CLSI).

Addition of Organic Soil Load

[0035] A 0.10 mL aliquot of FBS was added to 1.90 mL of each broth culture to yield a 5% fetal bovine serum soil load.

Antiseptic Exposure

[0036] An inoculum of 0.100 mL of each organism suspension was added to 9.9 mL of the antiseptic and vortexed to mix. The test mixture was exposed for 30 seconds, 1 minute, 3 minutes and 5 minutes at ambient temperature (25°C and 21 °C on the days tested).

Neutralization and Subculture

[0037] At each exposure period, a 1.00 mL sample was removed from each test mixture and added to 9 mL of neutralizer representing a 10° dilution of the neutralized inoculated test mixture. A 5 mL aliquot of the 10° neutralized inoculated test mixture was added to a sterile 0.45 μm filter apparatus pre-wet with 10.0 mL of 0.85% sterile saline. The sample was filter concentrated. The filter was rinsed with approximately 50 mL of 0.85% sterile saline, removed from the apparatus, and transferred to the appropriate agar plate. Additional 1 :10 serial dilutions were prepared from the 10° neutralized inoculated test mixture in Butterfield's Buffer. One (1.0) mL aliquots of the lO '-lO^"4 dilutions of neutralized inoculated test mixture were plated in duplicate on BAP plates for all test organisms with the exception of Streptococcus pneumoniae and Streptococcus pyogenes which had 0.10 mL aliquots of the 10°-10^"3 dilutions of neutralized inoculated test mixture plated in duplicate on BAP plates.

Incubation and Observation

[0038] The bacterial subculture plates were incubated for 48±4 hours at 35-37⁰C with the exception of Streptococcus pneumoniae and Streptococcus pyogenes plates which were incubated for 2-4 days at 35-37°C with 5-7% CO₂. Following incubation, the agar plates were observed visually for the presence of growth. The colony forming units were enumerated and the number of survivors at each exposure time was determined.

Study Controls

Test Population Control

[0039] In a similar manner as the culture inoculum was added to the antiseptic, an equivalent volume (0.100 mL) of each inoculum was added to 9.9 mL of Butterfield's Buffer (same volume as the antiseptic). This suspension was neutralized as in the test procedure and serially diluted. One (1.0) mL aliquots of the lO^-lO^"4 dilutions of neutralized inoculated test mixture were plated in duplicate on BAP plates for all test organisms with the exception of Streptococcus pneumoniae and Streptococcus pyogenes which had 0.10 mL aliquots of the 10°-10^"3 dilutions of neutralized inoculated test mixture plated in duplicate on BAP plates. The plates were incubated as in the test procedure. Following incubation, the organism plates were observed to enumerate the concentration of the test organism present in the antiseptic at the time of testing (time 0 analysis). The acceptance criterion for this study control is growth and the value is used for calculation purposes only. Purity Control

[0040] A "streak plate for isolation" was performed on each organism culture and following incubation examined in order to confirm the presence of a pure culture. The acceptance criterion for this study control is a pure culture demonstrating colony morphology typical of the test organism.

Initial Suspension Population Control

[0041] Each prepared test organism suspension was serially diluted and plated using standard microbiological techniques (1.00 mL aliquots of appropriate dilutions were plated for all test organisms with the exception of Streptococcus pneumoniae and Streptococcus pyogenes which had 0.10 mL aliquots of the appropriate dilutions plated). Following incubation, the organism plates were observed to enumerate the concentration of the test organism inoculated into the antiseptic at the time of testing. The acceptance criterion for this study control is growth of ≥i.O x 10⁶ CFU/mL.

Neutralizer Sterility Control

[0042] A representative sample of uninoculated neutralizer was incubated and observed. The acceptance criterion for this study control is lack of growth.

Organic Soil Sterility Control

[0043] The serum used for soil load was cultured, incubated, and observed for lack of growth. The acceptance criterion for this study control is lack of growth.

Neutralization Control

[0044] To simulate testing conditions, 9.9 mL of the antiseptic was inoculated with 0.1 mL Butterfield's Buffer in place of the test organism suspension (NC Suspension).

[0045] 1. Filtration Neutralization: A 1.0 mL aliquot of the NC Suspension was transferred to 9.0 mL neutralizing broth and mixed thoroughly. The control suspension (5.0 mL) was filter concentrated and the filter was rinsed as in the test procedure. An aliquot (1.0 mL) of an organism suspension containing approximately 100 CFU/mL was added to the filter apparatus and processed through the apparatus. An aliquot (1.0 mL) of the organism suspension was added to a second filter apparatus to be used as an inoculum population control and processed. The filters were aseptically transferred to recovery agar plates and incubated. The acceptance criteria for this study control requires the filtration neutralization control and corresponding population control results to be within 1.0 Log.

[0046] 2. Chemical Neutralization: A 1.0 mL aliquot of the NC Suspension was transferred to 9.0 mL neutralizing broth and mixed thoroughly. A 1.0 mL aliquot of the neutralized sample was then removed and discarded. To the neutralized sample, 1.0 mL of the organism suspension (containing approximately 10,000 CFU/mL for Streptococcus pneumoniae and Streptococcus pyogenes and approximately 1000 CFU/mL for all other test organisms ) was added and mixed thoroughly. An aliquot (0.10 mL for Streptococcus pneumoniae and Streptococcus pyogenes and 1.00 mL for all other test organisms) of the neutralized mixture was plated in duplicate and incubated. An inoculum population control was performed by adding 1.0 mL of the same organism suspension to 9.0 mL of Butterfi eld's Buffer and plating in duplicate as described above and incubating. The acceptance criterion for this study control requires the chemical neutralization control and corresponding population control be within 1.0 Log.

Study Acceptance Criteria

Antiseptic Performance Criteria

[0047] This study is designed to examine the rate-of-kill of an antiseptic after inoculation with a test organism. Results are expressed in percent and log reduction of the test organism. Minimum percent and log reduction values do not exist to specify a "passing" or "failing" antiseptic.

Control Acceptance Criteria

[0048] The study controls must perform according to the criteria detailed in the study controls description section. Data Analysis

Calculations

Test Data CFU/mL:

(avg. # colonies found/plate ( dilution used) (dilution factor)(volume neutralized solution)

(volume plated)

Percent Reduction: [1 -(test survivors/test population control)] x 100

LoglO Reduction: Logio (test population control) - Logio (test survivors)

References

[0049] The protocol for this test was based on the "Guide for Assessment of Microbiocidal Activity Using a Time-Kill Procedure" (American Society for Testing and Materials (ASTM), E2315-03, Volume 11.05, Copyright 2005 ASTM international); and the "Tentative Final Monograph for Healthcare Antiseptic Drug Products, Proposed Rule" (Food and Drug Administration, Code of Federal Regulations, 21 CFR parts 333 and 369. June 17, 1994).

Results and Analysis

[0051] Control and neutralization results are shown in Tables 2-5 and 8. All data measurements/controls, including neutralization confirmation, purity, initial suspension, test population, organic soil load sterility and neutralizer sterility controls performed within acceptance criteria listed in the study controls section above.

[0052] Test results for the antiseptic are shown in Tables 6 and 7.

Table 2: Control Results. The following results from controls confirmed study validity:

Table 3 : Initial Suspension Population Control

CFU = Colony Forming Unit

Table 4: Filtration Neutralization Controls

Table 5: Chemical Neutralization Controls

Table 6: Test Results

Table 6 continued:

* Note the spread plate results for Streptococcus pyogenes was considered invalid due to a chemical neutralization control failure.

Table 6 continued:

* Note the filtration plate results for the filtration of 5 mL of the 10 dilution of Serratian 5 marcescens was considered invalid due to a filtration neutralization control failure

Table 7: Calculated Test Data

* colony forming units per mL of test mixture

Table 7 continued:

* colony foπning units per mL of test mixture

Table 7 continued:

* colony forming units per mL of test mixture

Table 8: Verification of Antibiotic Resistance

*CLSI = Clinical and Laboratory Standards Institute

[0052] The results of this testing shows an acceptable rate of antiseptic activity.

[0053] Although preferred embodiments of the invention have been described herein, it will be understood by those skilled in the art that vaπations may be made thereto and that features of the descπbed embodiments may be combined without departing from the spiπt of the invention or the scope of the appended claims All documents mentioned in this application are hereby incorporated by reference in their entirety.

Claims

CLAIMS:

1. An antiseptic comprising a one to four carbon alkyl alcohol and at least one of lactic acid and a lactic acid salt, and a solvent.

2. The antiseptic of claim 1, wherein the solvent is water.

3. The antiseptic of claim 3, wherein the alkyl alcohol is present at 5.0% to 50.0% w/w.

4. The antiseptic of claim 4, wherein the alkyl alcohol is present at 20% to 40% w/w.

5. The antiseptic of claim 5, wherein alkyl alcohol is present at 30% w/w.

6. The antiseptic of any one of claims 1 to 5, wherein the alkyl alcohol is ethanol.

7. The antiseptic of any one of claims 1 to 6, wherein the at least one of lactic acid and a lactic acid salt is present at 0.1% to 10.0% w/w.

8. The antiseptic of claim 7, wherein the at least one of lactic acid and a lactic acid salt is present at 0.5% to 5.0% w/w.

9. The antiseptic of claim 8, wherein the at least one of lactic acid and a lactic acid salt is present at 3.0% w/w.

10. The antiseptic of any one of claims 1 to 9, wherein the at least one of lactic acid and a lactic acid salt is lactic acid.

11. The antiseptic of any one of claims 1 to 10, further comprising at least one additional antimicrobial agent selected from the group consisting of: quaternary ammonium compounds, triclosan, hydrogen peroxide, hydrogen peroxide-generating compounds, and mixtures thereof.

12. The antiseptic of any one of claims 1 to 11, further comprising a thickener.

13. The antiseptic of claim 12, wherein the thickener is selected from the group consisting of: polyacrylate, polyacrylic polymer, cellulose derivate, and mixtures thereof.

14. The antiseptic of claim 13, wherein the cellulose derivate is selected from the group consisting of: hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropylmethyl cellulose, xantham gum, and mixtures thereof.

15. The antiseptic of claim 14, wherein the cellulose derivate is hydroxyethyl cellulose.

16. The antiseptic of any one of claims 12 to 15, wherein the thickener is present at 0.1% to 5.0% w/w.

17. The antiseptic of claim 16, wherein the thickener is present at 0.5% to 3.0% w/w.

18. The antiseptic of claim 17, wherein the thickener is present at 1.0% w/w.

19. The antiseptic of any one of claims 1 to 18, further comprising a neutralizer.

20. The antiseptic of claim 19, wherein the neutralizer is selected from the group consisting of: sodium hydroxide, potassium hydroxide, triethanolamine, and mixtures thereof.

21. The antiseptic of claim 20, wherein the neutralizer is sodium hydroxide.

22. The antiseptic of any one of claims 19-21, wherein the neutralizer is present at 0.1% to 2% w/w.

23. The antiseptic of claim 22, wherein the neutralizer is present at 0.6% w/w.

24. The antiseptic of any one of claims 1 to 23, further comprising a surfactant.

25. The antiseptic of claim 24, wherein the surfactant is selected from the group consisting of: an ethoxylated alcohol, sodium laureth sulphate, sodium lauryl sulphate, an alkyl betaine, an alkyl polyglycoside, and mixtures thereof.

26. The antiseptic of claim 25, wherein the surfactant is a mixture of an alkyl polyglycoside and sodium lauryl sulphate.

27. The antiseptic of claim 26, wherein the alkyl polyglycoside is present at 0.1% to 5% w/w.

28. The antiseptic of claim 27, wherein the alkyl polyglycoside is present at 1% to 3% w/w.

29. The antiseptic of claim 28, wherein the alkyl polyglycoside is present at 1.66% w/w.

30. The antiseptic of any one of claims 26 to 29, wherein sodium lauryl sulphate is present at 0.1% to 5.0% w/w.

31. The antiseptic of claim 30, wherein sodium lauryl sulphate is present at 0.5% to 3.0% w/w.

32. The antiseptic of claim 31 , wherein sodium lauryl sulphate is present at 1.0% w/w.

33. The antiseptic of any one of claims 1 to 32, further comprising an emollient.

34. The antiseptic of claim 33, wherein the emollient is selected from the group consisting of: chamomile extract, aloe vera extract, and mixtures thereof.

35. The antiseptic of claim 34, wherein the emollient is chamomile extract.

36. The antiseptic of any one of claims 33 to 35, wherein the emollient is present at 0.05% w/w.

37. The antiseptic of any one of claims 1 to 36, further comprising a fragrance.

38. The antiseptic of claim 37, wherein the fragrance is present at 0.1% w/w.

39. An antiseptic comprising ethanol at 30% w/w, lactic acid at about 3% w/w, sodium hydroxide at 0.6% w/w, hydroxyl ethyl cellulose at 1% w/w, chamomile extract at 0.05% w/w, and water making up the balance.

40. An antiseptic comprising ethanol at 30% w/w, lactic acid at about 3% w/w, sodium hydroxide at 0.6% w/w, sodium lauryl sulphate at 1% w/w, alkyl polyglycoside at 1.66% w/w, chamomile extract at 0.05% w/w, and water making up the balance.

41. A hand sanitizer comprising the antiseptic of any one of claims 1 to 40.

42. An antimicrobial skin cleaner comprising the antiseptic of any one of claims 1 to 40.