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Drugs and Health Products

Anti-Dandruff Products

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

  • By submitting a PLA referencing this monograph, the applicant is attesting that the product will comply fully with the recommended conditions of use outlined in this monograph. The conditions of use include methods of preparations, source materials, doses, durations of use, combinations of medicinal ingredients, and risk statements.
  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

October 12, 2006

Anti-dandruff products are classified as natural health products (NHPs) if they contain ingredient(s) from Table 1. Applicants applying for a natural product number (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

Anti-dandruff products are classified as drugs if they contain an ingredient from Table 2. Applicants applying for a drug identification number (DIN) can access the appropriate forms and templates at:

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

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

Table 1 Footnotes

Table 1 Footnote 1

Ingredient must be pharmacopoeial grade (for a list of acceptable pharmacopoeial grades, see the Compendium of Monographs.) or requires citation of an approved NHP Master File, authorized by a letter of access issued to the applicant by the NHP Master File's registered owner.

Return to Table 1 footnote 1* referrer

Table 1 Footnote 2

The CAS number may be provided as additional information.

Return to Table 1 footnote 2+ referrer

Salicylic acid
(Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)

2-hydroxybenzoic acid
(Gottschalck and McEwen 2006; O'Neil et al. 2001)
Salicylic acid
(Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)
Salicylic acid *
(Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)
CAS No. 000069-72-7 +
1.8 - 3.0%
(FDA 1991)
Selenium sulfide
(Gottschalck and McEwen 2006; USP 29)
Selenium sulfide
(Gottschalck and McEwen 2006; USP 29)
Selenium sulfide *
(Gottschalck and McEwen 2006; USP 29)
CAS No. 007488-56-4 +
0.5 - 2.5%
(Sweetman 2002)
Sulfur
(Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)
Sulfur
(Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)
Sulfur *(Gottschalck and McEwen 2006; USP 29; O'Neil et al. 2001)
CAS No. 007704-34-9 +
2 - 5%
(FDA 1991)
Table 2: Drug medicinal ingredients
Medicinal ingredient preferred name Synonyms and other recognized names Quantity

Table 2 Footnotes

Table 2 Footnote 1

Pyrithione zinc is permitted at concentrations of 1-2% 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.

Return to Table 2 footnote 11 referrer

Coal tar - 0.5 - 10.0%
Pyrithione zinc - 0.1 - 2.0% 1

Route(s) of administration

Topical (FDA 1991)

Dosage form(s)

Those that are suited to the allowable route of administration and are established scientifically recognized dosage forms.

Use(s) or Purpose(s)

Statement to the effect of:

For the relief of (controls, helps prevent, and/or reduces the recurrence of) dandruff and/or the symptoms (itching, irritation, redness, flaking and/or scaling) associated with dandruff (FDA 1991)

Dose(s)

Subpopulation

Subpopulation does not need to be specified.

Quantity(ies)

See Tables 1 and 2.

Permitted combinations:

The only permitted combination is salicylic acid and sulfur (Gupta and Nicol 2004):
Salicylic acid: 1.8 - 3.0% + Sulfur: 2 - 5%

Directions for use:

Statement(s) to the effect of:

For products formulated to be applied and rinsed off (shampoos and rinses):

  • Apply evenly to scalp, leave on for several minutes, and then rinse off.  (Optional: repeat application) (Sweetman 2002).
  • Use at least twice per week or as directed by a health care practitioner (FDA 1991).

For products formulated to be applied and left on:
Apply to scalp one to four times daily or as directed by a health care practitioner (FDA 1991).

Duration of use

No statement is required.

Risk information

Statement(s) to the effect of:

Cautions and warnings

For all products:

  • For external use only (Sweetman 2002; FDA 1991).
  • Avoid contact with eyes.  If contact occurs, rinse thoroughly with water (FDA 1991).
  • Consult a health care practitioner if condition worsens or does not improve after regular use of this product (FDA 1991).
  • Consult a health care practitioner prior to use in children under 2 years of age (Berardi et al. 2002).

Contraindications

For products containing selenium sulfide:
Do not use within 48 hours of applying hair colours or permanent waving preparations (Sweetman 2002; Carruthers-Czyzewski et al. 1996).

Non-medicinal ingredients

  • The International Nomenclature for Cosmetic Ingredients (INCI) will be accepted.
  • For products containing Table 1 medicinal ingredients:
    Ingredients must be chosen from the current NNHPD List of Acceptable Non-medicinal Ingredients and must meet the limitations outlined in the list.
  • Other ingredients currently accepted as cosmetic ingredients will also be considered.

Specifications

  • This monograph describes those requirements that are specific to this class of drugs and to natural health products (NHPs).
    Note that requirements described in the Regulations to the Food and Drugs Act must be met.
  • 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 medicinal ingredients only:
    Products must comply with the minimum specifications outlined in the current NNHPD Compendium of Monographs.

References

  • 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.
  • BP 2003:  The British Pharmacopoeia. British Pharmacopoeia Commission.  London (UK): Her Majesty’s Stationary Office; 2003.
  • Carruthers-Czyzewski P, Gillis C, Letwin D, editors.  Nonprescription Drug Reference for Health Professionals. Ottawa (ON): Canadian Pharmaceutical Association; 1996.
  • FDA 1991: USA Department of Health and Human Services: Food and Drug Administration.Next link will take you to another Web site21 CFR 358. Dandruff, seborrheic dermatitis, and psoriasis drug products for over-the-counter human use: final rule; 1991. [Accessed 2006-01-24].
  • Gottschalck TE, McEwen GN, editors.  International Cosmetic Ingredient Dictionary and Handbook. 10th edition.  Washington (DC): Cosmetic, Toiletry and Fragrance Association; 2006.
  • Gupta AK, Nicol K.  The use of sulfur in dermatology.  Journal of drugs in dermatology. 2004; 3:427-431.
  • 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.
  • Sweetman SC, editor.  Martindale: The Complete Drug Reference, 33rd edition.  Grayslake (IL): Pharmaceutical Press; 2002.
  • USP 29:  The United States Pharmacopeia and the National Formulary (USP 29/NF 24). Rockville (MD): United States Pharmacopeial Convention, Inc.; 2006.