Code of Federal Regulations (Last Updated: November 8, 2024) |
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 |
§ 346.18 - Astringent active ingredients.
Latest version.
-
§ 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]