Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; technical amendment. Final rule; technical amendment.
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.
D017607:Aluminum Compounds / Q000145:classification*; D001252:Astringents / Q000145:classification*; D003257:Consumer Product Safety; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D004366:Nonprescription Drugs; D017592:Skin Care; D014481:United States; D014486:United States Food and Drug Administration
D017607:Aluminum Compounds; D001252:Astringents; D004366:Nonprescription Drugs