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Electronic Code of Federal Regulations

e-CFR data is current as of May 28, 2020

Title 21Chapter ISubchapter DPart 346Subpart B → §346.18


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.

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]

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