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astringent drug |
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According to the warning letter, "because this product is intended to stop bleeding, it is an astringent drug and must comply with the final over-the-counter drug monograph under Title 21 of the Code of Federal Regulations, Part 347 (21 CFR 347), Subpart A, "Skin Protectant Drug Products For Over-The-Counter Human Use--Astringent Drug Products. Because this product is intended to stop bleeding, it is an astringent drug and must comply with the final over-the-counter drug monograph under Title 21 of the Code of Federal Regulations, Part 347 (21 CFR 347), Subpart A, "Skin Protectectant Drug Products For Over-The-Counter Human Use--Astringent Drug Products," the warning letter stated. Moreover, because the product is intended to stop bleeding, it is an astringent drug and it must comply with the required, final over-the-counter (OTC) drug monograph for "Skin Protectant Drug Products for Over-The-Counter Human Use--Astringent Drug Products. |
astringent drug |
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