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Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; technical amendment. Final rule; technical amendment.
Fed Regist. 2009 Mar 06; 74(43):9759-65.FR

Abstract

We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for over-the-counter (OTC) skin protectant astringent drug products. This amendment clarifies that aluminum acetate solutions, produced by dissolving aluminum sulfate tetradecahydrate and calcium acetate monohydrate in powder or tablet form in water, are generally recognized as safe and effective (GRASE) and not misbranded as astringent drug products. The amendment also describes how manufacturers should relabel these products to comply with the FM. We are issuing this amendment in response to a citizen petition (CP) that we received from a manufacturer of OTC astringent drug products. This final rule is part of our ongoing review of OTC drug products.

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Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

Aluminum CompoundsAstringentsConsumer Product SafetyDrug LabelingHumansLegislation, DrugNonprescription DrugsSkin CareUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19418638

Citation

Food and Drug Administration, HHS. "Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products for Over-the-counter Human Use; Technical Amendment. Final Rule; Technical Amendment." Federal Register, vol. 74, no. 43, 2009, pp. 9759-65.
Food and Drug Administration, HHS. Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; technical amendment. Final rule; technical amendment. Fed Regist. 2009;74(43):9759-65.
Food and Drug Administration, HHS. (2009). Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; technical amendment. Final rule; technical amendment. Federal Register, 74(43), 9759-65.
Food and Drug Administration, HHS. Astringent Drug Products That Produce Aluminum Acetate; Skin Protectant Drug Products for Over-the-counter Human Use; Technical Amendment. Final Rule; Technical Amendment. Fed Regist. 2009 Mar 6;74(43):9759-65. PubMed PMID: 19418638.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; technical amendment. Final rule; technical amendment. A1 - ,, PY - 2009/5/8/entrez PY - 2009/5/8/pubmed PY - 2009/5/16/medline SP - 9759 EP - 65 JF - Federal register JO - Fed Regist VL - 74 IS - 43 N2 - We (Food and Drug Administration (FDA)) are amending the final monograph (FM) for over-the-counter (OTC) skin protectant astringent drug products. This amendment clarifies that aluminum acetate solutions, produced by dissolving aluminum sulfate tetradecahydrate and calcium acetate monohydrate in powder or tablet form in water, are generally recognized as safe and effective (GRASE) and not misbranded as astringent drug products. The amendment also describes how manufacturers should relabel these products to comply with the FM. We are issuing this amendment in response to a citizen petition (CP) that we received from a manufacturer of OTC astringent drug products. This final rule is part of our ongoing review of OTC drug products. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/19418638/Astringent_drug_products_that_produce_aluminum_acetate L2 - http://edocket.access.gpo.gov/2009/pdf/E9-4746.pdf DB - PRIME DP - Unbound Medicine ER -