Skin Protectant Drug Products for Over-the-Counter Human Use; Astringent Drug Products; Final Monograph; Proposed Rule

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The Food and Drug Administration (FDA) is proposing to amend 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 would revise 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 would add labeling for certain small packages (styptic pencils). This action is part of FDA's ongoing review of OTC drug products. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.