21 C.F.R. § 346.16 Analgesic, anesthetic, and antipruritic active ingredients.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients
§ 346.16 Analgesic, anesthetic, and antipruritic active ingredients.