21 CFR § 346.10 Anorectal Drug Products for Over-the-Counter Human Use

§ 346.10 Local anesthetic 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) Benzocaine 5 to 20 percent.

(b) Benzyl alcohol 1 to 4 percent.

(c) Dibucaine 0.25 to 1 percent.

(d) Dibucaine hydrochloride 0.25 to 1 percent.

(e) Dyclonine hydrochloride 0.5 to 1 percent.

(f) Lidocaine 2 to 5 percent.

(g) Pramoxine hydrochloride 1 percent.

(h) Tetracaine 0.5 to 1 percent.

(i) Tetracaine hydrochloride 0.5 to 1 percent.

← § 346.3 Definitions.§ 346.12 Vasoconstrictor active ingredients. →