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■ 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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