21 C.F.R. § 346.18 Astringent active ingredients.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients
§ 346.18 Astringent active ingredients.
