Code of Federal Regulations · Section
§ 346.18 — Astringent Active Ingredients
21 C.F.R. § 346.18
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The active ingredient of the product consists of any of the following when used within the concentration range established for each ingredient:
(a) Calamine, within a concentration range of 5 to 25 percent by weight per dosage unit (based on the zinc oxide content of calamine).
(b) Witch hazel, 10 to 50 percent.
(c) Zinc oxide, within a concentration range of 5 to 25 percent by weight per dosage unit.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321