Anti-Dandruff Products

Date

2026-06-26

FOREWORD

This monograph intends to replace the Anti-dandruff Products Monograph dated December 7, 2018. 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 products to be applied on the scalp for the control of dandruff. 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 anti-dandruff 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.

Notes

• Text in parentheses is additional optional information which can be included on the label at the applicant's discretion.
• The solidus (/) indicates that either term and/or statement may be selected on the label.

Medicinal ingredient(s)

Anti-dandruff products are classified as natural health products (NHPs) if they contain at least one ingredient listed in Table 1 and do not contain any ingredient listed in Table 2. Applicants applying for an NPN can access the appropriate forms and guidance at: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription.html.

Anti-dandruff products are classified as non-prescription drugs (NPDs) if they contain at least one ingredient from Table 2. Applicants applying for a DIN can access the appropriate forms and guidance at: http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/index_e.html.

¹At least one of the following references was consulted per proper name, common name, and source ingredient: RSC 2025; USP-NF 2024; Nikitakis and Lange 2016.
²Ingredient must be pharmacopoeial grade (for a list of acceptable pharmacopoeial grades, see the Quality of Natural Health Products Guide).
³At least one of the following references was consulted per dosage: ASHP 2026; FDA 2021.
⁴Selenium sulfide that has been finely ground and that has a median particle size of approximately 5 micrometers (µm), with not more than 0.1% of the particles greater than 15 µm and not more than 0.1% of the particles less than 0.5 µm.

¹Pyrithione zinc is permitted at concentrations of 0.3 - 2% in products intended to be applied and rinsed off after brief exposure and permitted at concentrations of 0.1 - 0.25% in products intended to be applied and left on the scalp.
²Coal tar is to be expressed as % from a coal tar solution (USP or equivalent) of X%. The permitted concentration of coal tar portion in the final product is 0.5 - 5% Coal tar.
³Coal tar [from X% coal tar solution (USP or equivalent)] at concentration 1.8% in addition to dl-Menthol or l-Menthol at 1.5% is permitted only in products to be applied and rinsed off after brief exposure.

Route of administration

Topical

Dosage form(s)

Acceptable dosage forms for NHPs

• Cream; Emulsion; Foam; Gel; Liquid; Lotion; Ointment; Paste; Shampoo; Shampoo, suspension; Solution; Suspension; Topical liquid

Acceptable dosage forms for NPDs

• Cream; Emulsion; Shampoo; Solution; Suspension

Use(s) or Purpose(s)

All products

• For the relief of/Controls/Helps prevent/Fights/Reduces/Helps eliminate/Helps stop the symptoms of dandruff (US FDA 2021).
• Helps prevent (the) recurrence of/Reduces (the) recurrence of/Controls (the) recurrence of/Fights (the) recurrence of/Helps eliminate (the) recurrence of/Helps stop (the) recurrence of the symptoms of dandruff (US FDA 2021).
• For the relief of/Controls/Helps prevent/Fights/Reduces/Helps eliminate/Helps stop skin/scalp itching/irritation/redness/flaking/(and) scaling associated with dandruff (US FDA 2021).
• Helps prevent (the) recurrence of/Reduces (the) recurrence of/Controls (the) recurrence of/Fights (the) recurrence of/Helps eliminate (the) recurrence of/Helps stop (the) recurrence of skin/scalp itching/irritation/redness/flaking/(and) scaling associated with dandruff (US FDA 2021).

Note: For NPDs, products making any of the above claims are eligible for the labelling flexibilities set out in section 2.6 of the Labelling requirements for non-prescription drugs guidance document.

Dose(s)

Subpopulation(s)

Children 2 to 11 years; Adolescents 12 to 17 years; Adults 18 years and older

Quantity(ies)

See Tables 1 and 2.

Permitted Combinations

The permitted combinations are:

• Salicylic acid and sulfur: Salicylic acid: 1.8 - 3% + Sulfur: 2 - 5% (US FDA 2021).
• Coal tar and dl/l-Menthol (for rinse-off products only): Coal tar solution: 1.8% (w/v) + dl/l-Menthol: 1.5% (US FDA 2021).

Directions for use

Products formulated to be applied and rinsed off

• (Shake well). Apply evenly to (wet) scalp, leave on for several/2-3 minutes, and then rinse off. (Repeat application and rinsing) (ASHP 2026).
• (For best results) use at least twice per week or as directed by a health care practitioner/health care provider/health care professional/doctor/physician/pharmacist (US FDA 2021).

Products formulated to be applied and left on

(Shake well). Apply to scalp 1 to 4 times daily or as directed by a health care practitioner/health care provider/health care professional/doctor/physician/pharmacist (US FDA 2021).

Products containing more than 1% selenium sulfide

After the first 2 weeks of treatment, apply once every 1 to 4 weeks or as directed by a health care practitioner/health care provider/health care professional/doctor/physician/pharmacist (ASHP 2026).

Duration(s) of Use

No statement is required.

Risk information

Caution(s) and Warning(s)

All products

• For external use only (US FDA 2021).
• When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water (US FDA 2021).
• Stop use and ask a health care practitioner/health care provider/health care professional/doctor/physician if condition worsens or does not improve after regular use of this product (US FDA 2021).
• Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Products containing coal tar

• When using this product use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application (US FDA 2021).

Products containing coal tar (Optional)

• When using this product light coloured hair, clothing, and skin may be stained.

Contraindication(s)

Products containing selenium sulfide or coal tar

• Do not use within 48 hours of applying hair colours, bleaching agents, tinted/tinting agents, or permanent waving preparations (Krinsky et al. 2017; CTMA 2016; CPMA 2016).

Products containing coal tar or more than 1% selenium sulfide

• Do not use for prolonged periods without asking a health care practitioner/health care provider/health care professional/doctor/physician.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

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.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations or the Food and Drug Regulations.

Specifications

This monograph describes those requirements that are specific to this class of NPDs and NHPs. Any change to the manufacturing process, beyond those included in the monograph, 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.

Products containing Table 1 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.

Products containing Table 2 medicinal ingredients

Requirements described in the Regulations to the Food and Drugs Act must be met.

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

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

References

• ASHP: American Society of Health-System Pharmacists. Selenium Sulfide (Topical) (Monograph). Medically reviewed by Drugs.com on Apr 30, 2026. [Accessed 2026 May 28]. Available from: https://www.drugs.com/monograph/selenium-sulfide-topical.html
• BP 2018: The British Pharmacopoeia. British Pharmacopoeia Commission. London (UK): Her Majesty's Stationary Office; 2018.
• Compendium of products for minor ailments (CPMA). Power B, et al., editors. Canadian Pharmacists Association; 2016.
• Compendium of therapeutics for minor ailments (CTMA). Power B et al., editors. Canadian Pharmacists Association; 2016.
• Guidelines for Consumer Advertising of Health products for Nonprescription drugs, Natural Health Products, Vaccines and Medical Devices. Ad Standards; 2018.
• Guidelines for the Nonprescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims. Ad Standards; 2016.
• Health Canada 2015: Quality of Natural Health Products Guide. Health Canada, May 2015. [Accessed 2026 May 21]. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/quality-guide.html
• Krinsky DL, Ferreri SP, Hemstreet B, Hume AL, Newton GD, Rollins CJ, Tietze KJ. Handbook of Nonprescription Drugs: An interactive approach for Self-Care, 19^th edition. Washington (DC): American Pharmaceutical Association; 2017 (Chapter 34).
• Nikitakis J, Lange B, editors. International Cosmetic Ingredient Dictionary and Handbook. 16^th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association; 2016.
• RSC 2025: Royal Society of Chemistry: The Merck Index Online; 2025. [Accessed 2026 May 21]. Available from: https://merckindex.rsc.org/
• US FDA 2021: USA Department of Health and Human Services: Food and Drug Administration. Over-the-Counter (OTC) Monograph M032: Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis for Over-the-Counter Human Use [Accessed 2026 May 21]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTC%20Monograph_M032-Drug%20Products%20for%20the%20Control%20of%20Dandruff%20Seborrheic%20Dermatitis%20and%20Psoriasis%2012.16.2021.pdf
• USP-NF 2023: United States Pharmacopeia and the National Formulary. Rockville (MD): United States Pharmacopeial Convention, Inc.; 2023.

Version History

¹Was previously a Cat IV monograph of the Therapeutic Products Directorate (former name).