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Drugs and Health Products


Antiseptic Skin Cleansers (Personal Domestic Use)

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Date

February 9, 2016

FOREWORD

This monograph describes the requirements necessary to receive marketing authorization (a Natural Product Number (NPN) or a Drug Identification Number (DIN)) for topical antiseptic hand cleansers intended for domestic/personal care use. Domestic/personal care antiseptic products are self-selected by a consumer from a retail outlet for their own personal household use as part of a skin cleansing routine. These types of products are intended to provide a superficial and non-persistent cleaning effect to reduce transient bacterial load on hands.

This monograph does not apply to antiseptic products intended for personal use in a commercial or institutional setting (e.g. workplaces, washrooms in public buildings), or for professional use in food-handling premises or in healthcare settings (e.g. hospitals, nursing homes, clinics, dental offices). The monograph also does not apply to personal use antiseptic products for wound cleansing, or application to sites other than the hands. Products which do not meet the criteria outlined in this document should apply outside of the monograph stream. Applicants/sponsors should consult the Human-Use Antiseptic Drugs guidance document and/or request a pre-submission meeting to discuss appropriate supporting data. For products intended as wound cleansers, applicants should refer to the First Aid Antiseptics monograph.

Domestic/personal care products should be used sparingly and are not a substitute for the use of plain soap and water. Antiseptic skin cleansers should be recommended for use on lightly soiled hands only as a second-line approach or when soap and water are not available.

Antiseptic skin cleansers are classified as natural health products (NHPs) if they contain an ingredient listed in Table 1 and do not contain any ingredient listed in Table2. Applicants seeking to obtain a NPN can access the appropriate Forms and Guidance.

Antiseptic skin cleansers are classified as non-prescription drugs if they contain an ingredient listed in Table 2. Applicants seeking to obtain a DIN can access the appropriate Forms and Guidance.

Note: The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. Text in parentheses is additional optional information which can be included on the Product Licence Application form and label at the applicant’s discretion.

Medicinal Ingredient(s)

Table 1: NHP medicinal ingredients and associated doses

Proper Name1 Common Name1 Source Material2 Quantity3

Table 1 footnotes

Table 1 footnote 1

At least one of the following references was consulted: O'Neil et al. 2001; Gottschalck and McEwen 2006; USP 38

Return to table 1 footnote 1 referrer

Footnote 2

At least one of the following references was consulted: O'Neil et al. 2001; USP 38

Return to table 1 footnote 2 referrer

Footnote 3

At least one of the following references was consulted: WHO 2005; Sweetman 2002; Zimmerman 1993

Return to table 1 footnote 3 referrer

Ethanol

Ethyl alcohol

Anhydrous alcohol

Ethanol

Ethyl alcohol

Anhydrous alcohol

Ethanol

60-80%

Isopropanol

Isopropyl alcohol

2-propanol

Isopropanol

Isopropyl alcohol

Isopropanol

60-70%

Table 2: Drug medicinal ingredients and associated doses

Medicinal ingredient preferred name Quantity
Benzalkonium chloride 0.1 - 0.15%
Benzethonium chloride 0.05 - 0.5%
Chlorhexidine gluconate 2 - 4%
Chloroxylenol 0.5 - 3%
Triclosan 0.1 - 1%

Permitted Combinations of Ingredients:

No combinations are permitted.

Route of administration

Topical

Dosage form(s) Footnote 4

Acceptable dosage forms include: Lotion, solution, cream, gel, liquid, wipes, ointment, spray [including non-pressurized sprays, continuous (bag-on-valve) sprays, and aerosol {non-chlorofluorocarbon (CFC)} based sprays].

Use(s) or Purpose(s) Footnote 5

Statement(s) to the effect of:

Directions of use

Statement(s) to the effect of:

For all products:

  • For personal domestic use
  • Supervise children when they use this product. Footnote 9

For products intended as handrubs or wipes:

For products intended as handwashes:

  • Lather in hands with water for at least 30 seconds. Rinse well. Footnote 10

Duration of use

For occasional use.

Risk information

Cautions and warnings

Statement(s) to the effect of:

For all products:

  • Keep out of reach of children. Footnote 10
  • For external use only. If accidental ingestion occurs, call a Poison Control Center immediately. Footnote 11
  • Avoid contact with the eyes. If contact occurs, flush eyes with water. Footnote 11
  • If irritation develops, discontinue use and consult a health care practitioner. Footnote 6,Footnote 12

For products containing ethanol or isopropanol:

  • Flammable. Keep away from open flame and sources of heat. Footnote 7

Contraindication(s)

For products containing a medicinal ingredient from Table 2:

  • Do not use if you are allergic to any of the ingredients.

Known Adverse Reaction(s)

No statement is required.

Non-medicinal ingredients

Non-medicinal ingredients must be chosen from the current Natural Health Products Ingredients Database (NHPID) Footnote 13 and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR) Footnote 14, the Herbs used as Non-medicinal Ingredients in Non-prescription Drugs for Human Use Footnote 15 policy, and/or the current Cosmetic Ingredient Hotlist Footnote 16, when relevant.

Specifications

For all products:

This monograph describes requirements that are specific to this class of drugs and to 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.

All personal hand use products are expected to demonstrate in vivo and in vitro efficacy against bacteria at a minimum. Such data is maintained on file with the applicant/sponsor unless filing outside of the monograph. See the Human-Use Antiseptic Drugs guidance document for recommended test methods [Section 5 - Tables 1 and 2]. Claims for fungi, mycobacteria and/or viruses require additional supporting data outside of the monograph.

For products containing ingredients listed in Table 1 NHP medicinal ingredients:

The finished product must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide.

For products containing ingredients from Table 2 drug medicinal ingredients:

Products must comply with the requirements in the Food and Drugs Act and associated Regulations. It is also noted that all products are subject to Part C, Division 2 of the Food and Drug Regulations.

When applicable, the medicinal ingredient(s) should comply with the specifications outlined in the associated monograph from the standards listed on Schedule B to the Food and Drugs Act.

Where no Schedule B monograph exists for the finished product's dosage form, specifications should be similar to those of a comparable compendial dosage form demonstrating the product's identity, potency, purity and quality.

Products that contain medicinal ingredients not included in Table 2 may be considered New Drugs as per section C.08.001 of the Food and Drug Regulations.

References cited

  • Ascenzi JM. Handbook of Disinfectants and Antiseptics. New York (NY): Marcel Dekker; 1996.
  • 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, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.
  • Gottschalck TE, McEwen GN, editors. International Cosmetic Ingredient Dictionary and Handbook. 11th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association; 2006.
  • Government of Canada 2015: Food and Drugs Regulations. Government of Canada, last amended on 2015 June 13. [Accessed 2015 September 18]. Available from: http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.%2C_c._870/
  • Health Canada 1995: Herbs used as Non-medicinal Ingredients in Nonprescription Drugs for Human Use. Health Canada, September 1995. [Accessed 2015 November 10]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/herbnonmed_pol-eng.php
  • Health Canada 2009: Guidance Document: Human-Use Antiseptic Drugs. Health Canada, December 2009. [Accessed 2015 September 18]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/antiseptic_guide_ld-eng.php#star91
  • Health Canada 2013: Quality of Natural Health Products Guide. Health Canada, May 2013. [Accessed 2015 September 18]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php
  • Health Canada 2014a: Cosmetic Ingredient Hotlist. Health Canada 2014. [Accessed 2015 September 18]. Available from: http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-critique/hotlist-liste-eng.php
  • Health Canada 2014b: Guidance Document: Labelling of Pharmaceutical Drugs for Human Use. Health Canada, January 2014.
  • Health Canada 2015: Natural Health Products Ingredients Database. Health Canada 2015; last amended on 2015 September 14. [Accessed 2015 September 18]. Available from: http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th edition. Whitehouse Station (NJ): Merck & Co., Inc; 2001.
  • Sweetman SC, editor. Martindale: The Complete Drug Reference. 33rd edition. London (UK): Pharmaceutical Press; 2002.
  • Trampuz AT, Widmer AF. Hand hygiene: a frequently missed lifesaving opportunity during patient care. Mayo Clinic proceedings. Mayo Clinic. 2004; 79:109-116.
  • US FDA 1994: United States Food and Drug Administration. 21 CFR Parts 333 and 369. Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products. Federal Register, Volume 59, Number 116, June 17, 1994. [Accessed 2015 September 18]. Available from: Next link will take you to another Web sitehttp://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4098B1_02_03-FDA-TAB1.pdf
  • US FDA 2013a: United States Food and Drug Administration. 21 CFR Parts 310 and 333. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record. Federal Register, Volume 78, Number 242, December 17, 2013. [Accessed 2015 September 18]. Available from: Next link will take you to another Web site https://federalregister.gov/a/2013-29814
  • USP 38: The United States Pharmacopeia and the National Formulary (USP 38/NF 33). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2015.
  • WHO 2005: WHO guidelines on hand hygiene in health care (advance draft). Geneva (Switzerland): World Health Organization Press; 2005.
  • Zimmerman DR. Zimmerman's Complete Guide to Nonprescription Drugs. Detroit (MI): Gale Research Inc.; 1993.

References reviewed

  • AHFS 2014: American Hospital Formulary Service®. McEvoy GK (ed). Next link will take you to another Web siteAHFS Drug Information 2014®.[Internet] Published by Authority of the Board of the American Society of Health-System Pharmacists®, Bethesda, Maryland. [Accessed 2014 April 10].
  • Aiello AE, Larson EL, Levy SB. Consumer Antibacterial Soaps: Effective or Just Risky? Clinical Infectious Diseases. 2007;45(Supplement 2):S137-S147.
  • CDC 2005: Centers for Disease Control and Prevention. Guideline for Hand Hygiene in Health-Care Settings: Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. MMWR 2002; Volume 51(No. RR-16)
  • Guideline for Hand Hygiene in Health-Care Settings. Morbidity and Mortality Weekly Report. Volume 51, Number RR-16, October 25, 2002.
  • Health Canada 2003: Guidance for Industry: Product Monograph. Health Canada, October 2003.
  • Health Canada 2005: Draft Guidance for Industry: Impurities in Existing Drug Substances and Products. Health Canada, September 2005.
  • US FDA 1991: United States Food and Drug Administration. 21 CFR Parts 333 and 369. Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for First Aid Antiseptic Drug Products; [Internet]. Federal Register, Volume 56, Number 140, July 22, 1991. [Accessed 2015 September 18]. Available from:Next link will take you to another Web sitehttp://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm079337.pdf
  • US FDA 2013b: United States Food and Drug Administration. FDA Drug Safety Communication: FDA requests label changes and single-use packaging for some over-the-counter topical antiseptic products to decrease risk of infection; [Internet]. Drug Safety Communication, November 13, 2013. [Accessed 2015 September 18]. Available from: Next link will take you to another Web site http://www.fda.gov/downloads/Drugs/DrugSafety/UCM374870.pdf

Footnotes

Footnote 4

Consult Appendix 1 for dosage forms that fall outside of the monograph.

Return to footnote 4 referrer

Footnote 5

Consult Appendix 2 for uses or purposes that fall outside of the monograph.

Return to footnote 5 referrer

Footnote 6

Berardi et al. 2002

Return to footnote 6 referrer

Footnote 7

Ascenzi 1966

Return to footnote 7 referrer

Footnote 8

Trampuz and Widmer 2004

Return to footnote 8 referrer

Footnote 9

US FDA 2013a

Return to footnote 9 referrer

Footnote 10

Health Canada 2009

Return to footnote 10 referrer

Footnote 11

Zimmerman 1993

Return to footnote 11 referrer

Footnote 12

US FDA 1994

Return to footnote 12 referrer

Footnote 13

Health Canada 2015

Return to footnote 13 referrer

Footnote 14

Government of Canada 2015

Return to footnote 14 referrer

Footnote 15

Health Canada 1995

Return to footnote 15 referrer

Footnote 16

Health Canada 2014a

Return to footnote 16 referrer

Appendix 1: Dosage forms that fall outside the scope of this monograph

The following dosage forms for antiseptic products are associated with indications of use that fall outside the scope of this monograph:

  • Sponge
  • Shampoo
  • Bar soaps
  • Swabs

These, as well as all other dosage forms not identified as acceptable in the ‘Dosage form(s)’ section of this document, require assessment outside of the monograph stream.

Appendix 2: Uses or purposes that fall outside the scope of this monograph

The following indications for antiseptic products would require a review outside of the monograph. Applicants/sponsors should consult the Human-Use Antiseptic Drugs guidance document and/or request a pre-submission meeting to discuss appropriate supporting data. These include, but are not limited to:

  • For use on any body part other than hands.
  • Antiseptic for use on large areas of the body (e.g. pre-operative showering or bathing).
  • For use at the pre-injection or catheter insertion site.
  • For use during or after skin piercing (e.g. ear piercing, tattoo).
  • For wound cleansing.
  • For use in a commercial or institutional setting.
  • For professional food handler or healthcare use.
  • Anti-viral.
  • Anti-mycobacterial.
  • Antifungal.
  • Log or % reduction claims (e.g. Kills 99.99% of bacteria).
  • Efficacy against/highlighting of any specific organisms.
  • Persistence claims.
  • Sterile.
  • Any claim that implies that the product provides an instantaneous/immediate effect.