21 Food and Drugs 5 2018-04-01 2018-04-01 false Analgesic, anesthetic, and antipruritic active ingredients. § 346.16 Section § 346.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Active Ingredients
§ 346.16 Analgesic, anesthetic, and antipruritic active ingredients.

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.