21 CFR § 349.18 Ophthalmic Drug Products for Over-the-Counter Human Use

§ 349.18 Ophthalmic vasoconstrictors.

Current through Sep 8, 2026 · Read all of Part 349

The active ingredient of the product consists of one of the following, within the established concentration for each ingredient:

(a) Ephedrine hydrochloride, 0.123 percent.

(b) Naphazoline hydrochloride, 0.01 to 0.03 percent.

(c) Phenylephrine hydrochloride, 0.08 to 0.2 percent.

(d) Tetrahydrozoline hydrochloride, 0.01 to 0.05 percent.

← § 349.16 Ophthalmic hypertonicity agent.§ 349.20 Eyewashes. →