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Drugs and Health Products

First Aid Antiseptics

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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.

Date

February 9, 2016

Medicinal Ingredient(s)

Table 1: NHP medicinal ingredients and associated doses
Proper name(s)  1 Common name(s) 1 Source material(s) 2 Quantity 3

Table 1 Footnotes

Table 1 Footnote 1

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

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

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

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

At least one of the following references was consulted: Khan and Naqvi 2006; Pray 2006; Carruthers-Czyzewski 1996; US FDA 1991

Return to Table 1 footnote3 referrer

  • Hydrogen peroxide
  • Hydrogen peroxide

Hydrogen peroxide

3%

  • 1-Ethenyl-2-pyrrolidinone homopolymer compound with iodine
  • 1-Vinyl-2-pyrrolidinone polymers, iodine complex
  • Povidone-iodine

Povidone-iodine

0.5-10%

Table 2: Non-prescription drug medicinal ingredient and associated doses
Medicinal ingredient preferred name 4 Quantity 4

Table 2 Footnotes

Table 2 Footnote 4

US FDA 1991

Return to Table 2 footnote 44 referrer

Benzalkonium chloride 0.1-0.13%
Benzethonium chloride 0.1-0.2%

Permitted Combinations of Medicinal Ingredients

No combinations are permitted.

Route(s) of Administration

Topical

Dosage Form(s)

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

Use(s) or Purpose(s) Footnote 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.

Directions for use Footnote 6

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

For products containing povidone-iodine:

  • Consult a health care practitioner/professional before use on infants.  Footnote 7
  • Consult a health care practitioner/professional before use if you have a thyroid disease. Footnote 7

For products containing benzalkonium chloride or benzethonium chloride:

  • If you are pregnant or breastfeeding, consult a health care practitioner/professional prior to use.

Contraindication(s)

For products containing povidone-iodine:

  • If you are pregnant or breastfeeding, do not use. Footnote 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 occur. Footnote 9

Non Medicinal Ingredients

Non-medicinal ingredients must be chosen from the current Natural Health Products Ingredients Database (NHPID) Footnote 10 and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR) Footnote 11, the Herbs used as Non-medicinal Ingredients in Non-prescription Drugs for Human Use policy Footnote 12, and/or the current Cosmetic Ingredient Hotlist Footnote 13, 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 .

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: Next link will take you to another Web site  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
  • 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: Next link will take you to another Web site  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: 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.
  • 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 Next link will take you to another Web site  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.
  • 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: Next link will take you to another Web site 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 Communication, November 13, 2013. [Accessed 2014 April 10]. Available from: Next link will take you to another Web site  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.

Footnotes

Footnote 5

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

Return to footnote 5 referrer

Footnote 6

US FDA 1991

Return to footnote 6 referrer

Footnote 7

US FDA 2013a

Return to footnote 7 referrer

Footnote 8

Zimmerman 1993

Return to footnote 8 referrer

Footnote 9

Gray et al. 2013; Palobart et al. 2009; Yoshida et al. 2008

Return to footnote 9 referrer

Footnote 10

Health Canada 2015

Return to footnote 10 referrer

Footnote 11

Government of Canada 2015

Return to footnote 11 referrer

Footnote 12

Health Canada 1995

Return to footnote 12 referrer

Footnote 13

Health Canada 2014a

Return to footnote 13 referrer

Footnote 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

Return to footnote 14 referrer

Appendix 1: Product Facts Table

PRODUCT facts table: recommended (not mandatory) Footnote 14

Product Facts Table