CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 346—ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE > SUBPART B—Active Ingredients (§346.10 to §346.22) > 346.18—Astringent 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.

Code of Federal Regulations

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