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Code · CFR · Title 21 — Food and Drugs · Part 349 — Ophthalmic Drug Products for Over-the-Counter Human Use · § 349.30

§ 349.30. Permitted combinations of active ingredients.

174 words·~1 min read·/us/cfr/t21/s§ 349.30·

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The following combinations are permitted provided each active ingredient is present within the established concentration, and the product is labeled in accordance with § 349.79.
(a)Any single ophthalmic astringent active ingredient identified in § 349.10 may be combined with any single ophthalmic vasoconstrictor active ingredient identified in § 349.18.
(b)Any two or three ophthalmic demulcent active ingredients identified in § 349.12 may be combined.
(c)Any single ophthalmic demulcent active ingredient identified in § 349.12 or any ophthalmic demulcent combination identified in paragraph
(b)of this section may be combined with any single ophthalmic vasoconstrictor identified in § 349.18.
(d)Any single ophthalmic astringent active ingredient identified in § 349.10 may be combined with any single ophthalmic vasoconstrictor active ingredient identified in § 349.18 and any single ophthalmic demulcent identified in § 349.12 or ophthalmic demulcent combination identified in paragraph
(b)of this section.
(e)Any two or more emollient active ingredients identified in § 349.14 may be combined as necessary to give the product proper consistency for application to the eye.
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