FIRST AID ANTISEPTICS

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 minor
wound cleansers. This monograph does not apply to antiseptic skin cleanser products for
personal hand hygiene or to products for professional use. Products which do not meet the
criteria outlined in this document should apply outside of the monograph stream.

First aid antiseptics are classified as natural health products (NHPs) if they contain an ingredient
listed in Table 1 and do not contain any ingredient listed in Table 2. Applicants seeking to obtain
a NPN can access the appropriate forms and guidance at http://www.hc-sc.gc.ca/dhp-mps/
prodnatur/applications/licen-prod/form/index_e.html.

First aid antiseptics 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 at
http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/index_e.html.

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 name(s)1 Common name(s)1 Source material(s)2 Quantity3

Hydrogen peroxide Hydrogen peroxide Hydrogen peroxide 3%
1-Ethenyl-2-pyrrolidinone
homopolymer compound with
iodine Povidone-iodine Povidone-iodine 0.5-10%

1-Vinyl-2-pyrrolidinone polymers,
1
At least one of the following references was consulted: USP 38; Gottschalck and McEwen 2006; O’Neil et al. 2001
2
At least one of the following references was consulted: USP 38; O’Neil et al. 2001
3
At least one of the following references was consulted: Khan and Naqvi 2006; Pray 2006; Carruthers-Czyzewski
1996; US FDA 1991
iodine complex

Table 2: Non-prescription drug medicinal ingredients and associated doses

Medicinal ingredient
Quantity4
preferred name4
Benzalkonium chloride 0.1-0.13%
Benzethonium chloride 0.1-0.2%

Permitted Combinations of Ingredients:

No combinations are permitted.

Route of administration

Topical

Dosage form(s)

Acceptable dosage forms include: Lotion, solution, cream, gel, liquid, ointment, wipes, swabs,
sprays.

Use(s) or Purpose(s)5

Statement(s) to the effect of:

For all products:

 First aid antiseptic.

 For minor wound cleansing.
 Antiseptic/Medicated/Antibacterial wound cleanser.
 Kills (harmful) bacteria/germs.
 Effective in destroying (harmful) bacteria to provide antiseptic cleansing.
 Helps to prevent (reduce the risk of) infection in minor cuts and scratches.

For products containing benzalkonium chloride or benzethonium chloride:

 First aid to help prevent (reduce the risk of) infection in minor burns.

4
US FDA 1991
5
At least one of the following references was consulted: Pray 2006; Berardi et al. 2002; Carruthers-Czyzewski
1996; US FDA 1991

First Aid Antiseptics - Page 2 of 10

Directions for use6

Statement(s) to the effect of:

For all products:

 Clean the affected area.

 Apply a small amount to wound one to three times daily.
 May be covered with a sterile bandage.
 Do not use on deep or puncture wounds, animal bites or serious burns.

Duration of use

For occasional use.

Risk information

Caution(s) and Warning(s):

Statement(s) to the effect of:

For all products:

 Keep out of reach of children.7

 For external use only. If swallowed, call a Poison Control Center or a health care
professional immediately.6,8
 Avoid contact with eyes. If contact occurs, flush thoroughly with water.6
 Do not apply over large areas of the body.6
 If symptoms worsen or persist after seven days, or if irritation develops, discontinue use
and consult a health care practitioner/professional.6,7

For products containing povidone-iodine:

 Consult a health care practitioner/professional before use on infants.7

 Consult a health care practitioner/professional before use if you have a thyroid disease.7

For products containing benzalkonium chloride or benzethonium chloride:

 If you are pregnant or breastfeeding, consult a health care practitioner/professional prior

to use.

6
US FDA 1991
7
US FDA 2013a
8
Zimmerman 1993

First Aid Antiseptics - Page 3 of 10

Contraindication(s)

For products containing povidone-iodine:

 If you are pregnant or breastfeeding, do not use.7

For products containing a medicinal ingredient from Table 2:

 If you are allergic to any of the ingredients, do not use.

Known Adverse Reaction(s)

For products containing povidone-iodine:

 Rare anaphylactic reactions have been known to occur9.

Non-medicinal ingredients

Non-medicinal ingredients must be chosen from the current Natural Health Products Ingredients
Database (NHPID)10 and must meet the limitations outlined in that database, the Food and Drug
Regulations (FDR)11, the Herbs used as Non-medicinal Ingredients in Nonprescription Drugs for
Human Use policy12, and/or the current Cosmetic Ingredient Hotlist13, when relevant.

Specifications

For all products:

This monograph describes requirements that are specific to this class of non-prescription 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.

For products containing ingredients from Table 1: NHP medicinal ingredients and associated
doses:

The finished product must be established in accordance with the requirements described in the
NNHPD Quality of Natural Health Products Guide, available at http://www.hc-sc.gc.ca/
dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php.

9
Gray et al. 2013; Palobart et al. 2009; Yoshida et al. 2008
10
Health Canada 2015
11
Government of Canada 2015
12
Health Canada 1995
13
Health Canada 2014a

First Aid Antiseptics - Page 4 of 10

For products containing ingredients from Table 2: Non-prescription drug medicinal ingredients
and associated doses:

Health Canada’s Guidance Document: Labelling of Pharmaceutical Drugs for Human Use
should be consulted for applicable labelling requirements.

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.08.001of the Food and Drug Regulations.

References cited

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.

Carruthers-Czyzewski P, editor. Nonprescription Drug Reference for Health Professionals. 1st

edition. Ottawa (ON): Canadian Pharmaceutical Association; 1996.

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 2015; 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/

Gray Pe, Katelaris CH, Lipson D. Recurrent anaphylaxis caused by topical povidone-iodine
(Betadine). Journal of paediatrics and child health 2013;49(6):506-507.

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

First Aid Antiseptics - Page 5 of 10

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

Khan MN and AH Naqvi. Antiseptics, iodine, povidone iodine and traumatic wound cleansing.
Journal of tissue viability 2006;16(4):6-10.

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.

Palobart C, Cros J, Orsel I, Nathan N. Anaphylactic shock to iodinated povidone. Annales

françaises d’anesthésie et de réanimation 2009;28(2):168-170.

Pray WS. Nonprescription Product Therapeutics. 2nd edition. Baltimore (MD): Lippincott
Williams & Wilkins; 2006.

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 2014 April 10]. Available from: http://www.fda.gov/downloads/Drugs/
DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/
StatusofOTCRulemakings/ucm079337.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; [Internet]. Federal Register, Volume 78, Number 242, December 17,
2013. [Accessed 2014 April 10]. Available from: 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.

First Aid Antiseptics - Page 6 of 10

Yoshida K, Sakurai Y, Kawahara S, Takeda T, Ishikawa T, Murakami T, Yoshioka A.
Anaphylaxis to polyvinylpyrrolidone in povidone-iodine for impetigo contagiosum in a boy with
atopic dermatitis. International archives of allergy and immunology 2008;146:169-173.

Zimmerman DR. Zimmerman’s Complete Guide to Nonprescription Drugs. Detroit (MI): Gale
Research Inc.; 1993.

References reviewed

Arai K, Yamazaki M, Maeda T, Okura T, Tsuboi R. Influence of various treatments including

povidone-iodine and healing stimulatory reagents in a rabbit ear wound model. International
Wound Journal 2013;10(5):542-548.

Ascenzi JM. Handbook of Disinfectants and Antiseptics. New York (NY): Marcel Dekker; 1996.

Atiyeh BS, Dibo SA, Hayek SN. Wound cleansing, topical antiseptics and wound healing.
International wound journal 2009;6(6):420-430.

AHFS 2014: American Hospital Formulary Service®. McEvoy GK (ed). AHFS Drug
Information 2014®. [Internet] Published by Authority of the Board of the American Society of
Health-System Pharmacists®, Bethesda, Maryland. [Accessed 2014 April 10]. Available from
http://online.statref.com

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).

Geronemus RG, Mertz PM, Eaglstein WH. Wound healing. The effects of topical antimicrobial
agents. Archives of dermatology 1979;115(11):1311-1314.

Gilmore OJ, Reid C, Strokon A. A study of the effect of povidone-iodine on wound healing.
Postgraduate medical journal 1977;53(617):122-125.

Goldenheim PD. An appraisal of povidone-iodine and wound healing. Postgraduate medical

journal 1993;69(Suppl 3):S97-S105.

Gravett A, Sterner S, Clinton JE, Ruiz E. A trial of povidone-iodine in the prevention of

infection in sutured lacerations. Annals of emergency medicine 1987;16(2):167-171.

Guideline for Hand Hygiene in Health-Care Settings. Morbidity and Mortality Weekly Report.
Volume 51, Number RR-16, October 25, 2002.

First Aid Antiseptics - Page 7 of 10

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.

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

Juhasz I. Experiences with the use of povidone-iodine-containing local therapeutics in

dermatological surgery and in the treatment of burns: testing for allergic sensitization in
postsurgery patients. Dermatology 2002;204(Suppl 1):52-58.

Kramer SA. Effect of povidone-iodine on wound healing: a review. Journal of vascular nursing
1999;17(1):17-23.

Nili F, Hantoushzadeh S, Alimohamadi A, Shariat M, Rezaeizadeh G. Iodine-containing

disinfectants in preparation for caesarean section: impact on thyroid profile in cord blood.
Postgraduate medical journal 2015 -133540. doi: 10.1136. Epub ahead of print.

Norman D. The use of povidone-iodine in superficial partial-thickness burns. British journal of

nursing 2003;12(6 Suppl):S30-S36.

Peter FW, Li-Peuser H, Vogt PM, Muehlberger T, Homann HH, Steinau HU. The effect of
wound ointments on tissue microcirculation and leucocyte behaviour. Clinical and experimental
dermatology 2002;7(1):51-55.

Roberts AH, Roberts FE, Hall RI, Thomas IH. A prospective trial of prophylactic povidone
iodine in lacerations of the hand. Journal of hand surgery 1985;10(3):370-374.

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

Trampuz AT and Widmer AF. Hand hygiene: a frequently missed lifesaving opportunity during
patient care. Mayo Clinic proceedings 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; [Internet]. Federal Register, Volume 59, Number 116,
June 17, 1994. [Accessed 2014 April 10]. Available from:
http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4098B1_02_03-FDA-TAB1.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

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Communication, November 13, 2013. [Accessed 2014 April 10]. Available from:
http://www.fda.gov/downloads/Drugs/DrugSafety/UCM374870.pdf

WHO 2005: WHO guidelines on hand hygiene in health care. Geneva (Switzerland): World
Health Organization Press; 2005.

Zahidi A, Draoui M, Mestassi M. Iodine status and the use of iodized antiseptics in the mother-
newborn pair. Therapie 1999;54(5)545-548.

Zhen ZJ, Lai ECH, Lee QH, Chen HW, Lau WY, Wang FJ. Conventional wound management
versus a closed suction irrigation method for infected laparotomy wound – A comparative study.
International Journal of Surgery 2011;9:378-381.

First Aid Antiseptics - Page 9 of 10

Appendix 1: Products Facts Table

PRODUCT FACTS TABLE: RECOMMENDED (NOT MANDATORY)14

Product Facts
Active ingredient (in each dosage unit) Purpose
Benzethonium chloride OR Benzalkonium chloride XX %…..............……………First Aid Antiseptic

Uses
 First aid to help prevent (reduce the risk of) infection in minor cuts, scratches, and burns.
 For minor wound cleansing.
 Antiseptic/medicated/antibacterial wound cleanser.
 Kills harmful bacteria or germs.
 Effective in destroying bacteria to provide antiseptic cleansing.
Warnings
 For external use only.
 If you are pregnant or breastfeeding, consult a health care practitioner prior to use.
Do not use:
 if you are allergic to any ingredients in the product.
 in the eyes or over large areas of the body.
 on deep or puncture wounds, animal bites or serious burns.
Stop use and ask a doctor if:
 irritation develops.
 condition gets worse or persists after seven days .
When using this product:
 If contact with the eyes occurs, rinse with water.
Keep out of reach of children

If swallowed, call a Poison Control Centre or a health care professional immediately.

Directions
For occasional use.

 Clean the affected area.

 Apply a small amount to wound one to three times daily.
 May be covered with a sterile bandage.

Inactive ingredients <List all NMIs>

Questions? Concerns? Call 1-877-XXX-XXXX

14
The regulatory amendment for a Fact Table for non-prescription drug products would come into force three years
after the day of registration in Canada Gazette Part II (June 13, 2017).
http://gazette.gc.ca/rp-pr/p2/2014/2014-07-02/html/sor-dors158-eng.php

First Aid Antiseptics - Page 10 of 10