StacksVerified U.S. regulatory reference

21 CFR §349.30

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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.
  1. (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.
  2. (b)Any two or three ophthalmic demulcent active ingredients identified in § 349.12 may be combined.
  3. (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.
  4. (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.
  5. (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.