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Anorectal drug products for over-the-counter human use. Final rule.
Fed Regist. 2003 Aug 26; 68(165):51167-70.FR

Abstract

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.

Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

Drug EvaluationDrug Therapy, CombinationHumansHydrocortisoneMorpholinesNonprescription DrugsPruritus AniSafetyUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

12952012

Citation

Food and Drug Administration, HHS. "Anorectal Drug Products for Over-the-counter Human Use. Final Rule." Federal Register, vol. 68, no. 165, 2003, pp. 51167-70.
Food and Drug Administration, HHS. Anorectal drug products for over-the-counter human use. Final rule. Fed Regist. 2003;68(165):51167-70.
Food and Drug Administration, HHS. (2003). Anorectal drug products for over-the-counter human use. Final rule. Federal Register, 68(165), 51167-70.
Food and Drug Administration, HHS. Anorectal Drug Products for Over-the-counter Human Use. Final Rule. Fed Regist. 2003 Aug 26;68(165):51167-70. PubMed PMID: 12952012.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Anorectal drug products for over-the-counter human use. Final rule. A1 - ,, PY - 2003/9/4/pubmed PY - 2003/9/13/medline PY - 2003/9/4/entrez SP - 51167 EP - 70 JF - Federal register JO - Fed Regist VL - 68 IS - 165 N2 - 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. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/12952012/Anorectal_drug_products_for_over_the_counter_human_use__Final_rule_ DB - PRIME DP - Unbound Medicine ER -