21 CFR § 349.18
Ophthalmic vasoconstrictors
June 25, 2020
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.
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