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26 |
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작용기능(영) |
Drug Astringents - Oral Health Care Drugs |
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작용기능(한) |
의약품용 수렴제 - 구강 건강용품용 |
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설명(영) |
Drug Astringents-Oral Health Care Drugs are active ingredients used in oral health care drug astringent products. In the U.S., in a tentative final monograph published by the U.S. Food and Drug Administration, "Oral Health Care Drug Products for Over-the-Counter Human Use" (53 Fed. Reg. 2436, January 27, 1988), an astringent is defined as "an agent that causes contraction of the tissues or arrest of secretions by coagulation of proteins on a cell surface." In the EU and other countries, these products are considered to be cosmetics, and are controlled under cosmetic regulations which may not require pre-clearance or pre-market approval of active ingredients. In Japan, oral health care drug astringent agents may be regarded as drugs subject to pre-approval requirements. The listing below includes those reported to be safe and effective for use in U.S. over-the-counter (OTC) drug products. These ingredients may also have a cosmetic purpose in cosmetic formulations. To identify the currently allowed oral health care drug astringent agents in the U.S., or for information on ingredient use limitations, etc., the reader is directed to contact the U.S. Food and Drug Administration for the most recent information concerning this drug category. The U.S. approved drug ingredients are identifed below with a star prefix. Whenever the U.S. drug name differs from the INCI name, the U.S. drug name is presented parenthetically. |
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설명(한) |
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해당원료 |
AMMONIUM ALUM; |
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