21 CFR § 346.12
Vasoconstrictor active ingredients
June 25, 2020
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.