21 CFR § 346.12 Anorectal Drug Products for Over-the-Counter Human Use

§ 346.12 Vasoconstrictor 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 in the concentration or within the concentration range established for each ingredient.

(a) Ephedrine sulfate 0.1 to 1.25 percent.

(b) Epinephrine 0.005 to 0.01 percent.

(c) Epinephrine hydrochloride 0.005 to 0.01 percent.

(d) Phenylephrine hydrochloride 0.25 percent.

← § 346.10 Local anesthetic active ingredients.§ 346.14 Protectant active ingredients. →