원료정의
(Definitions) |
Calamine is a preparation consisting primarily of zinc oxide with the addition of approximately 0.5% ferric oxide. In the United States, Calamine may be used as an active ingredient in OTC drug products. When used as an active drug ingredient, the established name is Calamine.
이 원료는 소량의 페릭옥사이드를 함유한 징크옥사이드이다. 이 원료를 강열한 것은 정량할 때 징크옥사이드(ZnO:81.38) 98%이상을 함유한다. |
원료수재근거 |
■ U.S. Over-the-Counter (OTC) Drug Ingredients
U.S. OTC drug active ingredients are regulated by the U.S. FDA and require premarket approval for safety and efficacy. Some U.S. OTC drug active ingredients have been reported to have a purely cosmetic purpose in cosmetic formulations, in addition to being safe and effective drug ingredients.
Some U.S. OTC drug functions may be regulated as cosmetics in other countries. Such drug
functions may therefore be assigned to ingredients not approved for such use in the United States. In Section 4, Functions, ingredients approved for use as U.S. OTC drug active ingredients are identified by an asterisk. In addition, when a U.S. drug name differs from the INCI name, the U.S. drug name is listed parenthetically.
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