Topical antifungal drug products for over-the-counter human use; amendment of final monograph. Final rule.
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.
D000935:Antifungal Agents / Q000145:classification / Q000627:therapeutic use; D003022:Clotrimazole / Q000145:classification* / Q000627:therapeutic use; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D006801:Humans; D004366:Nonprescription Drugs; D014005:Tinea / Q000188:drug therapy; D014481:United States; D014486:United States Food and Drug Administration
D000935:Antifungal Agents; D004366:Nonprescription Drugs; D003022:Clotrimazole