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31 |
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작용기능(영) |
External Analgesics |
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작용기능(한) |
외부 진통제 |
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설명(영) |
External Analgesics are active ingredients used in local anesthetic, analgesic, and antipruritic external products. In 21CFR346.10, an anesthetic drug is defined as a drug that produces local disappearance of pain, burning, itching, irritation and/or discomfort. In 21CFR346.3, an external analgesic, anesthetic drug is defined as a topically applied drug that relieves pain by depressing cutaneous sensory receptors. See 21CFR346.10 and 21CFR346.16 for a listing of active ingredients. In the EU and other countries, external analgesic 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, external analgesics 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 external analgesics 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 |
ALOE BARBADENSIS LEAF EXTRACT; |
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