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This monograph is intended to replace the existing Acne Therapy Monograph of October 14, 2016. This monograph describes the requirements necessary to receive market authorization [i.e. a Drug Identification Number (DIN) or a Natural Product Number (NPN)], for topical acne therapy products. The monograph identifies the permitted medicinal and non-medicinal ingredients, concentrations, indications, directions and conditions of use for these products to be market authorized without the submission to Health Canada of additional evidence. It may also contain the test methods recommended to be used to comply with the requirements of this monograph. Products which do not meet the criteria outlined in this document can apply for market authorization outside of the monograph stream.

Applicants are reminded that acne therapy products, like other non-prescription drugs or natural health products, are subject to the Food and Drug Regulations or the Natural Health Products Regulations administered by the Natural and Non-prescription Health Products Directorate (NNHPD). This includes requirements related to labelling, manufacturing and product specifications. Additional information on labels, outside of those specified in the monograph, such as additional directions for use and/or non-therapeutic claims are acceptable as long as they meet the Guidelines for the Nonprescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims, the Guidelines for Consumer Advertising of Health products for Nonprescription drugs, Natural Health Products, Vaccines and Medical Devices, and are not false, misleading or counterintuitive to the use of the product.

The development of this monograph is the result of a thorough review of existing regulations, guidance documents, policies and current practices within Health Canada and other leading regulatory agencies.


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.


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

Acne therapy products are classified as non-prescription drugs if they contain an ingredient from Table 2. Applicants applying for a DIN can access the appropriate forms and templates at:

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

Table 1 Footnotes

Table 1 Footnote 1

At least one of the following references was consulted per proper name, common name, and source material: O'Neil et al. 2018; USP 38.

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

The following reference was consulted for the dosage: FDA 2015.

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

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

Return to Table 1 footnote3 referrer

Table 1 Footnote 4

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 footnote4 referrer

2-Hydroxybenzoic acid

Salicylic acid

Salicylic acid





3-10% 3

  • 1,3-Benzenediol
  • m-Dihydroxybenzene



2% 4

1,3-Benzenediol, monoacetate

Resorcinol monoacetate

Resorcinol monoacetate

3% 4

Table 2: Non-prescription drug medicinal ingredient
Proper name(s) Common name(s) Source material(s) Quantity
Common name(s)
Benzoyl peroxide Benzoyl peroxide Benzoyl peroxide 2.5-5%




The following dosage forms are acceptable when used according to the requirements indicated in this monograph:

Acceptable dosage forms for Non-prescription drugs (NPDs):

Acceptable dosage forms for Natural Health Products (NHPs):


Self-Care Framework Category I Uses or Purposes:

For all products, the following statements may be made:

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

Unacceptable use(s) or purpose(s):

Statement(s) to the effect of:

Applications for products that recommend a sequential treatment regime or products co-packaged with another non-prescription 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.



Adolescents 12 to 17 years, Adults 18 years and older


See Tables 1 and 2.

Permitted Combinations

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

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

Directions for use

For all products:

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

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

For aerosols, aerosol sprays and sprays:

Duration of Use

No statement is required.


Caution(s) and Warning(s)

For all products:

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

For products containing Benzoyl Peroxide:


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

For products containing Benzoyl Peroxide:

Known Adverse Reaction(s)

For all products:

For products containing Benzoyl peroxide or Salicylic acid:


The alternative terms "physician/health care practitioner/health care provider/health care professional" are only acceptable for NHPs. Non-prescription drug labels must follow the requirements listed in Table 1 of the Guidance document: Labelling Requirements for Non-prescription Drugs.


Ingredients must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR), and the current Cosmetic Ingredient Hotlist , when relevant.


No statement required.


This monograph describes those requirements that are specific to this class of non-prescription 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 Table 1 NHP medicinal ingredients only:

The finished product specifications must be established in accordance with the requirements described in the NNHPD Quality of Natural Health Products Guide. The medicinal ingredient must comply with the requirements outlined in the NHPID.

For products containing Table 2 non-prescription drug medicinal ingredients:Requirements described in the Regulations to the Food and Drugs Act must be met.

DRUG FACTS TABLES (Format Optional for Self-Care Category I)

Drug Facts Table


AHFS 2015: American Hospital Formulary Service®. McEvoy GK (ed). AHFS Drug Information 2015®. [Internet] Published by Authority of the Board of the American Society of Health-System Pharmacists®, Bethesda, Maryland. [Accessed 2015 October 07]. Available from:

Krinsky DL, Ferreri SP, Hemstreet B, Hume AL, Newton GD, Rollins CJ, Tietze KJ. Handbook of Nonprescription Drugs: An interactive approach for 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. Available from [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 2015.09.22].

O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 2018 Whitehouse Station (NJ): Merck & Co., Inc; 2018.

Sweetman SC, editor. Martindale: The Complete Drug Reference. Online edition. Pharmaceutical Press; 2015 [Accessed 2015.10.07].

USP 38: The United States Pharmacopeia and the National Formulary (USP 38/NF 33). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2015.