Antiseptic Skin Cleansers

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Date: December 11, 2006

Antiseptic skin cleansers are classified as natural health products (NHPs) if they contain ingredients from Table 1. Applicants applying for a natural product number (NPN) can access the appropriate forms and guidance.

Antiseptic skin cleansers are classified as drugs if they contain any ingredients from Table 2. Applicants applying for a drug identification number (DIN) can access the appropriate forms and guidance.

Table 1: NHP medicinal ingredients

Proper name(s)	Common name(s)	Source material(s)	Quantity
Ethanol (O'Neil et al. 2001) Ethyl alcohol (O'Neil et al. 2001) Anhydrous alcohol (O'Neil et al. 2001)	Ethanol (O'Neil et al. 2001) Ethyl alcohol (O'Neil et al. 2001) Anhydrous alcohol (O'Neil et al. 2001)	Ethanol* (O'Neil et al. 2001) CAS No. 000064-17-5+	60-80% (WHO 2005)
Isopropanol (O'Neil et al. 2001) Isopropyl alcohol (Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001) 2-propanol (O'Neil et al. 2001; USP 29)	Isopropanol (O'Neil et al. 2001) Isopropyl alcohol (Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)	Isopropanol* (O'Neil et al. 2001) CAS No. 000067-63-0+	60-70% (Sweetman 2002)
Povidone-iodine (O'Neil et al. 2001; USP 29)	Povidone-iodine (O'Neil et al. 2001; USP 29;)	Povidone-iodine* (O'Neil et al. 2001; USP 29;) CAS No. 025655-41-8+	0.5-10.0% (Sweetman 2002; Zimmerman 1993)

* Ingredient must be pharmacopoeial grade (for a list of acceptable pharmacopoeial grades, see the Compendium of Monographs) or requires citation of an approved NHP Master File, authorized by a letter of access issued to the applicant by the NHP Master File's registered owner.
⁺The CAS number may be provided as additional information.

Table 2: Drug medicinal ingredients

Medicinal ingredient preferred name	Synonyms and other recognized names	Quantity
Benzalkonium chloride		0.1 - 0.15%
Benzethonium chloride		0.05 - 0.5%
Chlorhexidine gluconate		2.0 - 4.0%
Chloroxylenol		0.5 - 3.0%
Methylbenzethonium chloride		0.05 - 0.5%
Triclocarban		1.5% only
Triclosan		0.1 - 1.0 %

Route(s) of administration:

Topical

Dosage form(s):

Those that are suited to the allowable route of administration and are established, scientifically recognized dosage forms.

Use(s) or Purpose(s):

Statement(s) to the effect of:

For all products:

• Antiseptic cleanser (Berardi et al. 2002; Azcenzi 1996)
• Medicated cleanser (Berardi et al. 2002; Azcenzi 1996)
• Kills harmful bacteria or germs (Berardi et al. 2002; Azcenzi 1996)
• Effective in destroying certain bacteria and removing impurities to provide antiseptic cleansing (Berardi et al. 2002; Azcenzi 1996)
• For personal hand hygiene to help prevent the spread of certain bacteria (Trampuz and Widmer 2004; Azcenzi 1996).

For products containing povidone-iodine the following statement may be made:

• For wound cleansing (Berardi et al. 2002).

Dose(s):

Subpopulation: Subpopulation does not need to be specified.

Quantity: See Tables 1 and 2

Permitted combinations: No combinations are permitted.

Directions for use: Statement(s) to the effect of:

For all products except povidone-iodine:

• Use as part of your daily cleansing routine.

For products containing povidone-iodine:

• Apply to wound once or twice daily.

For products intended as hand sanitizers:

• Rub product onto hands and allow to dry.

Duration of use:

No statement is required.

Risk information:

Statement(s) to the effect of:

Cautions and warnings:

For all products:

• For external use only (Zimmerman 1993).
• Avoid contact with the eyes. If contact occurs, flush eyes with water (Zimmerman 1993).
• Discontinue use and consult a health care practitioner if irritation develops (Berardi et al. 2002).

For products containing ethanol or isopropanol only:

• Flammable. Keep away from open flame and sources of heat (Ascenzi 1996).

Contraindications:

No statement is required.

Non-medicinal ingredients:

The International Nomenclature for Cosmetic Ingredients (INCI) will be accepted.

For products containing Table 1 medicinal ingredients:
Ingredients must be chosen from the current NHPD List of
Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.
Other ingredients currently accepted as cosmetic ingredients will also be considered.

Specifications:

This monograph describes those requirements that are specific to this class of drugs and to natural health products (NHPs).

Any change to the manufacturing process that impacts the safety and efficacy of the ingredients, such as the use of novel technology (e.g. nanotechnology), requires supporting data and will be reviewed outside the monograph.

For products containing ingredients from Table 1 NHP medicinal ingredients:
Products must comply with the minimum specifications in the current NHPD Compendium of Monographs.

For products containing ingredients from Table 2 drug medicinal ingredients:
Products must comply with the requirements in the Regulations to the Food and Drugs Act.

Special Note:

This monograph applies to antiseptic skin cleansers intended for domestic / personal care use.

References:

Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13^th edition. Washington (DC): American Pharmaceutical Association; 2002.

FDA 2005: USA Department of Health and Human Services: Food and Drug Administration, 2005. 21 CFR Part 333. Topical Anti-Microbial Drug Products for Over-the-Counter Human Use, Final Monograph. [Accessed 2006-01-09]. Available at: www.fda.gov/cder/otcmonographs/Acne/acne(333D).pdf

Gottschalck TE, McEwen GN, editors. International Cosmetic Ingredient Dictionary and Handbook. 11^th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association; 2006.

O'Neil MJ,Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 13^th edition. Whitehouse Station (NJ): Merck and Co., Inc; 2001.

Sweetman SC, editor. Martindale: The Complete Drug Reference. 33^rd edition. London (UK): Pharmaceutical Press; 2002.

USP 29: The United States Pharmacopeia and the National Formulary (USP 29/NF 24). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2006.