21 C.F.R. § 349.18   Ophthalmic vasoconstrictors.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 349—OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart B—Active Ingredients

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§ 349.18   Ophthalmic vasoconstrictors.

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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