21 C.F.R. § 349.18 Ophthalmic vasoconstrictors.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 349—OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients
§ 349.18 Ophthalmic vasoconstrictors.