Code of Federal Regulations · Section
§ 346.16 — Analgesic, Anesthetic, And Antipruritic Active Ingredients
21 C.F.R. § 346.16
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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) Camphor 0.1 to 3 percent.
(b) Juniper tar 1 to 5 percent.
(c) Menthol 0.1 to 1 percent.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321