Labelling Standard for Miconazole, Clotrimazole and Naftifine for Treating Fungal Skin Infections.

Contact: BGIVD Enquiries

Category:

Naftifine and Imidazole antifungal agents

Application:

Cream, gel and liquid forms of antifungal agents for the treatment of fungal infections of the skin.

Medicinal Ingredients and Concentrations

The finished product and all ingredients used in the manufacture of the product should comply with the specifications of Schedule B pharmacopoeial or equivalent standard.

The medicinal ingredients of a product complying with this monograph consist of the following ingredients when used singly within the established limits given:

• clotrimazole nitrate, 1%, cream* and solution
• miconazole nitrate, 2%, cream* and solution
• naftifine hydrochloride, 1%, cream or gel

Note: these ingredients are subject to the requirements of Division 8, Part C of the Regulations to the Food and Drugs Act. Established OTC antifungal ingredients are included in the Labelling Standard for Topical Antifungals

* see also Labelling Standard for Intravaginal miconazole and clotrimazole

Adequate directions for use

Indications:

For the treatment of athlete's foot (tinea pedis), jock-itch (tinea-cruris) or ringworm (tinea corporis).

Other acceptable claims

• kills the fungus that causes athlete's foot/jock itch/ringworm
• relieves itching, scaling, burning and soreness of athlete's foot
• cures athlete's foot/jock itch/ringworm when used for the full treatment period (four weeks)

Claims not acceptable

• kills athlete's foot fungus on contact

Dosage Directions:

For the treatment of athlete's foot, jock itch or ringworm -

1. Cleanse skin with soap and water and dry thoroughly.
2. 1. Rub in a thin layer* on affected area twice daily for full treatment period - if there is no improvement within 2 weeks, consult a physician - otherwise, continue treatment for a week or two after symptoms have disappeared (up to a maximum of 4 weeks) - jock itch and ringworm usually require 2 weeks to resolve while athlete's foot may require 4 weeks. * Use "apply to affected area...." for solutions
   2. For athlete's foot
      (in applying medication) Pay special attention to spaces between toes.
3. Wear well fitting, ventilated shoes and cotton socks.

Warnings:

1. For external use only.
2. Do not use on children under 2 years of age.
3. Do not use for infections of the scalp or nails.
4. Avoid contact with eyes: if this happens, rinse thoroughly with water.
5. If new irritation occurs, consult a physician.
6. Do not use while pregnant or nursing except on the advice of a physician.

Note: This labelling standard 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 should also be met.

References

1. Department of Health and Human Services, Food and Drug Administration, Federal Register, Topical Antifungal Drug products for Over the Counter Human Use, Establishment of a Monograph, vol.47, No.56, pp 12480-12566, 1982
2. Facts and Comparisons Division, Drug Facts and Comparisons J.B. Lippincott Company, 1989.
3. United States Pharmacopeial Convention, Drug Information for the Health Care Professional, Vol. 1B, United States Pharmacopeial Convention, Inc., 1989.
4. American Hospital Formulary Service, Drug Information, American Society of Hospital Pharmacists, Inc., pp. 2101-2111, 1992.
5. American Medical Association, Drug Evaluations Annual 1992, pp. 1499-1502, 1992.
6. Gennaro, A.R. (Ed.), Remington's Pharmaceutical Sciences, 17th Ed. Mack Publishing Co., 1985.
7. Micromedex Inc. Drugdex Vol. 73, 1974 - 1992.
8. Gilman, A.G., Rall, T.W., Nies, A.S., Taylor, P. (Ed.) The Pharmacological Basis of Therapeutics, 8th Ed. Pergamon Press, pp. 1176-1177 and 1585, 1990.
9. Avery, G.S. (Ed.), Drug Treatment: Principles and Practice of Clinical Pharmacology and Therapeutics. Adis Press, pp. 1138,1236 1980.
10. Reynolds, J.E.F. (Ed.), Martindale: The Extra Pharmacopoeia 29th Ed. The Pharmaceutical Press, 1989.

Product Regulation Division
Bureau of Nonprescription Drugs
October 22, 1993