21 C.F.R. § 349.30

Permitted combinations of active ingredients.

Last amended: 2016Year: 2026Length: 174 wordsSubsections: 5Official source

Cite as 21 C.F.R. § 349.30 (2026)

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.
Cross-references to the CFR
349.10349.12349.14349.18349.18.349.79.
21 C.F.R. § 349.30: Permitted combinations of active ingredients. | Justis AI