21 CFR § 346.16 Anorectal Drug Products for Over-the-Counter Human Use

§ 346.16 Analgesic, anesthetic, and antipruritic 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) Camphor 0.1 to 3 percent.

(b) Juniper tar 1 to 5 percent.

(c) Menthol 0.1 to 1 percent.

← § 346.14 Protectant active ingredients.§ 346.18 Astringent active ingredients. →