Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 5 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER D - DRUGS FOR HUMAN USE
/ PART 346 - ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
/ Subpart B - Active Ingredients / § 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.