Category IV Monograph: Athletes Foot Treatments
This monograph applies to products in cream, ointment, lotion, gel, powder, spray powder, aerosol liquid, solution, foam, or soap form intended to treat athlete's foot by killing or inhibiting the growth and reproduction of the fungus tinea pedis. The medicinal ingredients and their concentrations in Category IV products are restricted to those specified in this monograph. The medicinal ingredients must be identified on product labelling by the names given in this monograph.
Table of Contents
All ingredient (medicinal and nonmedicinal) and finished product specifications should, as a minimum, meet the standards described in the publications referred to in Schedule B to the Food and Drugs Act, or equivalent standards. Where no Schedule B monograph exists for the dosage form, specifications should be similar to those of a comparable compendial dosage form. In the absence of a Schedule B standard for any dosage form, testing must be adequate to demonstrate the product's identity, potency, purity and quality.
Finished product specifications should include tests for identification and an assay with suitable limits for the medicinal ingredient(s) including its components. The specifications for all dosage forms should include a description of the dosage form including organoleptic properties as well as physico-chemical testing e.g., pH, specific gravity, viscosity, appropriate to the dosage form. Where antimicrobial preservatives are added, an assay with suitable limits should be included. It is recommended that antimicrobial preservative effectiveness be determined in order to establish that the product is capable of resisting microbial contamination.
|Chlorphenesin||0.5 - 1 %|
|Clioquinol (Iodochlorhydroxyquin)||3 %|
|Undecylenic acid||10 - 25 %|
|Calcium undecylenate||10 - 25 %|
|Copper undecylenate||10 - 25 %|
|Zinc undecylenate||10 - 25 %|
Combinations of Medicinal Ingredients
Two or more of the following may be combined provided that the combined ingredients provide a total undecylenate concentration of 10-25 %:
- undecylenic acid
- calcium undecylenate
- copper undecylenate
- zinc undecylenate
Nonmedicinal ingredients must be restricted to those substances, necessary for the formulation of the dosage form. Their concentration must not exceed the minimum required to provide their intended effect. They must be harmless in the amounts used, their presence must not affect the bioavailability, therapeutic efficacy or safety of the medicinal ingredients and they must not interfere with assays and tests for the medicinal ingredients and, if present, antimicrobial preservatives.
Ingredients of botanical origin added as non-medicinal ingredients must comply with the Drugs Directorate Policy, Herbs used as Non-medicinal Ingredients in Nonprescription Drugs for Human Use.
Herbal ingredients are not permitted except as fragrance components.
This monograph describes those requirements that are specific to this class of drugs. Other requirements described in the Regulations to the Food and Drugs Act and in the Guide for the Labelling of Drugs for Human Use must also be met.
Directions for Use
for the treatment of athlete's foot (tinea pedis)
The following statements are also acceptable:
cures athlete's foot (acceptable provided a direction "use daily for the full treatment period" is specified);
kills athlete's foot fungus;
relieves (itching, scaling, burning, cracking, redness, soreness, irritation) of athlete's foot.
For Tolnaftate: with daily use, for the prevention of athlete's foot, for individuals with recurring problems.
kills athlete's foot fungus on contact;
any reference to treatment of fungal nail infections.
- cleanse skin with soap and water and dry thoroughly;
- For treatment: apply (spray) a thin layer over affected area morning and night for full treatment period (4 weeks);
- For prevention: apply (spray) thin layer to feet once or twice daily;
- (in applying medication) pay special attention to spaces between toes;
- wear well-fitting, ventilated shoes and cotton socks.
- For external use only;
- Avoid contact with eyes; if this happens, rinse thoroughly with water;
- Do not use for infections of the nails;
- Do not use in children under 2 years of age, except on the advice of a doctor (or a direction that the product should be used by adults and children over 2 years);
- If irritation occurs or if there is no improvement following the full treatment period of 4 weeks, discontinue use and consult a doctor.
Appendix I Formulated Preparations
|Proper Name||USP 1995||BP 1993||BPC 1976|
|compound clioquinol topical powder||x|
|haloprogin topical solution||x|
|povidine-Iodine Cleansing Solution||x|
|povidone-iodine topical solution||x|
|tolnaftate topical aerosol powder||x|
|tolnaftate topical powder||x|
|tolnaftate topical solution||x|
|compound undecylenic acid ointment||x|
Athletes Foot Treatments. This Monograph has 5 pages. September 11, 1995.
Revisions after this date will be highlighted in bold and larger print.
Report a problem or mistake on this page
- Date modified: