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Skin protectant drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment.
Fed Regist. 2003 Dec 09; 68(236):68509-11.FR

Abstract

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM).

Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

Administration, TopicalDermatologic AgentsDrug LabelingHumansLipNonprescription DrugsProtective AgentsSkinUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

14664244

Citation

Food and Drug Administration, HHS. "Skin Protectant Drug Products for Over-the-counter Human Use; Final Monograph; Technical Amendment. Final Rule; Technical Amendment." Federal Register, vol. 68, no. 236, 2003, pp. 68509-11.
Food and Drug Administration, HHS. Skin protectant drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment. Fed Regist. 2003;68(236):68509-11.
Food and Drug Administration, HHS. (2003). Skin protectant drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment. Federal Register, 68(236), 68509-11.
Food and Drug Administration, HHS. Skin Protectant Drug Products for Over-the-counter Human Use; Final Monograph; Technical Amendment. Final Rule; Technical Amendment. Fed Regist. 2003 Dec 9;68(236):68509-11. PubMed PMID: 14664244.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Skin protectant drug products for over-the-counter human use; final monograph; technical amendment. Final rule; technical amendment. A1 - ,, PY - 2003/12/11/pubmed PY - 2004/1/6/medline PY - 2003/12/11/entrez SP - 68509 EP - 11 JF - Federal register JO - Fed Regist VL - 68 IS - 236 N2 - The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. This amendment revises several of the indications for OTC skin protectant drug products to provide additional labeling claims that should not have been excluded from the final monograph (FM). SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/14664244/Skin_protectant_drug_products_for_over_the_counter_human_use DB - PRIME DP - Unbound Medicine ER -