21 Food and Drugs 5 2018-04-01 2018-04-01 false Astringent active ingredients. § 346.18 Section § 346.18 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
§ 346.18 Astringent 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.

[55 FR 31779, Aug. 3, 1990, as amended at 59 FR 28767, June 3, 1994]