설명(영) |
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Skin Protectants are active ingredients used in skin protectant products. In the U.S., in 21CFR346.3(i), a protectant drug is defined as a drug which provides a physical barrier, forming a protective coating over skin or mucous membranes. See 21CFR346.14, 21CFR346.18, and 21CFR347.10 for a listing of the active drug ingredients.
In the EU and other countries, skin protectant 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, skin protectant agents 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 as well as those identified by suppliers as skin protectant agents. These ingredients may also have a cosmetic purpose in cosmetic formulations.
To identify the currently allowed skin protectants 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. |