21 CFR § 349.30 - Permitted combinations of active ingredients.
---
identifier: "/us/cfr/t21/s349.30"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 349.30 - Permitted combinations of active ingredients."
title_number: 21
title_name: "Food and Drugs"
section_number: "349.30"
section_name: "Permitted combinations of active ingredients."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "349"
part_name: "OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "53 FR 7090, Mar. 4, 1988, unless otherwise noted."
cfr_part: "349"
---
# 349.30 Permitted combinations of active ingredients.
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.