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Drugs and Health Products

ACNE THERAPY

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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 a product intended to treat/manage acne.

Acne therapy products 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.

Acne therapy products are classified as 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

October 14, 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: O'Neil et al. The Merck Index Online 2015; USP 38

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

At least one of the following references was consulted: O'Neil et al. The Merck Index Online 2015; USP 38

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

FDA Final Rule 2015; 21 CFR part 333 Topical Antimicrobial Drug Products for Over-The-Counter Human use

Return to Table 1 footnote3 referrer

Table 1 Footnote 4

The appropriate dosage range for sulfur in combination with resorcinol or resorcinol monoacetate is 3-8 % (FDA 2010)

Return to Table 1 footnote4 referrer

Table 1 Footnote 5

Resorcinol and Resorcinol monoacetate are not permitted as single medicinal ingredients and must be in combination with 3-8 % sulfur (FDA 2010).

Return to Table 1 footnote 5* referrer

  • Salicylic acid
  • 2-Hydroxybenzoic acid
  • Salicylic acid

Salicylic acid

CAS No. 69-72-7

0.5-2%

  • Sulfur
  • Sulfur

Sulfur

CAS No. 7704-34-9

3-10% 4

  • 1,3-Benzenediol
  • Resorcinol
  • Resorcinol

Resorcinol

CAS No. 108-46-3

2% *

  • 1,3-Benzenediol, monoacetate
  • Resorcinol monoacetate
  • Resorcinol monoacetate

Resorcinol monoacetate

CAS No. 102-29-4

3% *

Table 2: Drug medicinal ingredient and associated dose
Medicinal ingredient preferred name Quantity
Benzoyl peroxide 2.5-5%

Permitted Combinations of Medicinal Ingredients

The only permitted combinations are sulfur + resorcinol or resorcinol monoacetate (FDA 2010):

  • Sulfur: 3 - 8 % + Resorcinol: 2 %
  • Sulfur: 3 - 8 % + Resorcinol monoacetate: 3 %

Additional notes: Products containing resorcinol or resorcinol monoacetate in combination with sulfur cannot be indicated as body cleansers or as a face wash.

Route(s) of Administration

Topical

Dosage Form(s) Footnote 5

For all products (drugs and NHPs):

Acceptable dosage forms include: Lotion, cream, gel, solution, liquid, ointment, wipe, aerosol and paste.

For NHPs only:

Acceptable dosage forms also include: Bar soap and sponge.

Use(s) or Purpose(s) Footnote 6

Statement(s) to the effect of:

For all products:

  • For the treatment/management of acne.

One or more of the following statements may also be included:

  • Helps treat acne pimples (Optional: "and allow skin to heal").
  • Dries and helps clear up acne pimples (Optional: "and allow skin to heal").
  • Reduces the number and/or severity of acne pimples (Optional: "and allow skin to heal").
  • Penetrates pores to control (reduce) acne pimples.
  • Helps keep skin clear of new acne pimples.
  • Helps prevent new acne pimples from forming.

For products containing benzoyl peroxide, the following statement may be made:

  • Prevents and kills acne bacteria.
Unacceptable use(s) or purpose(s):

Statement(s) to the effect of:

  • Controls oil (oily skin).
  • Cures acne.

Directions for use

Statement(s) to the effect of:

For all products:

  • For New Users: Apply product to a small area once a day for three days to test if you are sensitive to this product.
  • If no discomfort occurs, cover the entire affected area with a thin layer.
  • Start with one application daily, then gradually increase to two or three times daily, if needed.
  • If dryness or peeling occurs, reduce application to once a day or every other day.

For products intended to be applied to the skin and left on:

  • Cleanse skin thoroughly before applying the product.

For products intended to be applied and rinsed from the skin:

  • Rinse off (optional: after x minutes).

Duration of Use

No Statement required.

Risk Information

Caution(s) and Warning(s)

Statement(s) to the effect of:

For all products:

  • For external use only. Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.
  • Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. If irritation occurs, use only one product at a time.
  • Avoid contact with eyes; if contact occurs, rinse thoroughly with water.
  • For more severe cases, and/or if improvement is not apparent within 6-8 weeks, consult a health care professional.

For products containing Sulfur or Sulfur in combination with Resorcinol or Resorcinol Monoacetate:

  • Apply only to areas with acne.

For products containing Benzoyl Peroxide:

  • Avoid contact with lips, mouth, and nostrils; if contact occurs, rinse with water.
  • Avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • Avoid unnecessary sun exposure and use a sunscreen.

Contraindication(s)

For products containing Sulfur or Sulfur in combination with Resorcinol or Resorcinol Monoacetate:

  • Do not use
    • on broken skin.
    • on large areas of the skin.

For products containing Benzoyl Peroxide:

  • Do not use if you
    • have very sensitive skin.
    • are allergic to benzoyl peroxide or any other ingredient in the product.

Known Adverse Reaction(s)

For all products:

  • If you develop severe irritation, burning or itching of the skin, discontinue use and consult a health care professional.
  • If you develop hives, swelling of eyes and mouth, blistering or difficulty breathing, get medical help right away.

Product Facts Table: Recommended (Not Mandatory)

Product Facts Table

Product Facts Table: Recommended (Not Mandatory)  Footnote 7

Product Facts Table

Non Medicinal Ingredients

Non-medicinal ingredients must be chosen from the current Natural Health Products Ingredients Database (NHPID) Footnote 8 and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR) Footnote 9, the Herbs used as Non-medicinal Ingredients in Non-prescription Drugs for Human Use Footnote 10 policy, and/or the current Cosmetic Ingredient Hotlist Footnote 11, when relevant.

Specifications

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

The finished product must be established in accordance with the requirements described in Health Canada's 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 the ingredient from Table 2: Drug medicinal ingredient:

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.08.001 of the Food and Drug Regulations.

Specifications for Drug Facts table can be found under section 2.4.4 of the guidance document: Good Label and Package Practice Guide for Non-prescription Drugs and Natural Health Products.

References

  • AHFS 2015: American Hospital Formulary Service®. McEvoy GK (ed). AHFS Drug Information 2015®. [Internet] Published by Authority of the Board of the American Soceity of Health-System Pharmacists®, Bethesda, Maryland. [Accessed 2015 October 07]. Available from: Next link will take you to another Web site http://online.statref.com
  • Daniel L. Krinsky, Stefanie P. Ferreri, Brian Hemstreet, Anne L. Hume, Gail D. Newton, Carol J. Rollins, Karen J. Tietze editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 18th edition. Washington (DC): American Pharmaceutical Association; 2015.
  • FDA 2015: USA Department of Health and Human Services: Food and Drug Administration, 2015 21CFR 333 subpart D Topical Acne Drug Products. [Accessed 2016.07.25].
  • FDA 2011: USA Department of Health and Human Services: Food and Drug Administration, 2011 Guidance for Industry OTC Acne Product Compliance guide
  • FDA 2010: USA Department of Health and Human Services: Food and Drug Administration, 2010. 21 CFR Part 333. Classification of Benzoyl Peroxide as Safe and Effective and Revision of Labeling to Drug Facts Format; Topical Acne Drug Products for Over-the-Counter Human Use, Final Rule. [Accessed 2015 September 22].
  • Health Canada Guidance Document, June 30, 2016. Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products.
  • O'Neil MJ, Maryadele J. The Merck Index Online: An Encyclopedia of Chemicals, Drugs, and Biologicals. 14th edition. Whitehouse Station (NJ): Merck and Co., Inc; 2015.
  • Sweetman SC, editor. Martindale: The Complete Drug Reference. Online edition. Pharmaceutical Press; 2015 [Accessed 2015 October 07].
  • USP 38: The United States Pharmacopeia and the National Formulary (USP 38/NF 33). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2015.

Footnotes

Footnote 5

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

Return to footnote 5 referrer

Footnote 6

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

Return to footnote 6 referrer

Footnote 7

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 7 referrer

Footnote 8

Health Canada 2015

Return to footnote 8 referrer

Footnote 9

Government of Canada 2015

Return to footnote 9 referrer

Footnote 10

Health Canada 1995

Return to footnote 10 referrer

Footnote 11

Health Canada 2014a

Return to footnote 11 referrer

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

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

  • Sponge (for drug products)
  • Shampoo
  • Bar soap (for drug products)

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: Applications that fall outside the scope of this monograph

Applications for products that recommend a sequential treatment regime or products co-packaged with another drug, natural health product or cosmetic product (as defined in the Guidance Document: Labelling of Pharmaceutical Drugs for Human Use) will be reviewed outside the monograph.

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.