CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART B—Active Ingredients (§346.10 to §346.22) > 346.16—Analgesic, anesthetic, and antipruritic 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.