GroundRules
21 CFR 346.18: Astringent active ingredients.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart B—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) Calamine, within a concentration range of 5 to 25 percent by weight per dosage unit (based on the zinc oxide content of calamine).
(b) Witch hazel, 10 to 50 percent.
(c) Zinc oxide, within a concentration range of 5 to 25 percent by weight per dosage unit.
Collected 2026-08-27T02:24:47Z. Source file · JSON