Anorectal drug products for over-the-counter human use. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule establishing that any over-the-counter (OTC) drug product containing a combination of hydrocortisone and pramoxine hydrochloride (HCl) for anorectal use is not generally recognized as safe and effective and is misbranded. This combination product is not currently marketed OTC. This final rule discusses data on the combination of hydrocortisone and pramoxine HCl that were still under review when an earlier final rule on OTC anorectal drug products was issued. This rule is part of FDA's ongoing review of OTC drug products.
D004341:Drug Evaluation; D004359:Drug Therapy, Combination; D006801:Humans; D006854:Hydrocortisone / Q000145:classification*; D009025:Morpholines / Q000145:classification*; D004366:Nonprescription Drugs / Q000145:classification*; D011538:Pruritus Ani / Q000188:drug therapy; D012449:Safety / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration
D009025:Morpholines; D004366:Nonprescription Drugs; D006854:Hydrocortisone