21 CFR § 346.18 Anorectal Drug Products for Over-the-Counter Human Use

§ 346.18 Astringent active ingredients.

Current through Sep 8, 2026 · Read all of Part 346

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]

← § 346.16 Analgesic, anesthetic, and antipruritic active ingredients.§ 346.20 Keratolytic active ingredients. →