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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 349 - Ophthalmic Drug Products for over-the-Counter Human Use |
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Subpart B - Active Ingredients |
§ 349.18 - Ophthalmic vasoconstrictors.
Latest version.
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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.