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.
Subject(s)
Aluminum Compounds/classification , Astringents/classification , Drug Labeling/legislation & jurisprudence , Nonprescription Drugs , Consumer Product Safety , Humans , Legislation, Drug , Skin Care , United States , United States Food and Drug AdministrationABSTRACT
The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant astringent drug products are generally recognized as safe and effective and not misbranded. This action revises some labeling for astringent drug products to be consistent with the final rule for OTC skin protectant drug products (68 FR 33362, June 4, 2003) and adds labeling for certain small packages (styptic pencils). This action is part of FDA's ongoing review of OTC drug products. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule.