Topical antifungal drug products for over-the-counter human use; amendment of final monograph. Final rule.

Abstract

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) topical antifungal drug products to add the ingredient clotrimazole as generally recognized as safe and effective for the treatment of athlete's foot, jock itch, and ringworm. This final rule is part of FDA's ongoing review of OTC drug products.

• Authors: Food and Drug Administration, HHS
• Journal: Federal register (Fed Regist) Vol. 67 Issue 27 Pg. 5942-3 (Feb 08 2002) ISSN: 0097-6326 [Print] United States
• PMID: 11837282 (Publication Type: Journal Article)

Chemical References

• Antifungal Agents
• Nonprescription Drugs
• Clotrimazole

Topics

• Antifungal Agents (classification, therapeutic use)
• Clotrimazole (classification, therapeutic use)
• Drug Approval (legislation & jurisprudence)
• Drug Labeling (legislation & jurisprudence)
• Humans
• Nonprescription Drugs
• Tinea (drug therapy)
• United States
• United States Food and Drug Administration