[ REC. # ] |
44 |
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작용기능(영) |
Oral Health Care Drugs |
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작용기능(한) |
구강 위생약품 |
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설명(영) |
Oral Health Care Drugs are active ingredients used in oral health care products. In the U.S., in a proposed rule 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 oral health care drug product is defined as "a drug product applied topically for the proper care of the oral cavity, including the temporary relief of symptoms of the mouth and throat, for example, occasional minor sore throat or mouth soreness." In the EU and other countries, oral health care 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 drugs may be regarded as drugs subject to pre-approval requirements. The listing below includes those ingredients 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 drugs 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 identified 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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