21 CFR 349.14
§ 349.14 Ophthalmic emollients.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 349.14, § 349.14 Ophthalmic emollients, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86655
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Full text
The active ingredients of the product consist of any of the following:
(a) Lanolin preparations:
(1) Anhydrous lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the monograph.
(2) Lanolin, 1 to 10 percent in combination with one or more oleaginous emollient agents included in the monograph.
(b) Oleaginous ingredients:
(1) Light mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph.
(2) Mineral oil, up to 50 percent in combination with one or more other emollient agents included in the monograph.
(3) Paraffin, up to 5 percent in combination with one or more other emollient agents included in the monograph.
(4) Petrolatum, up to 100 percent.
(5) White ointment, up to 100 percent.
(6) White petrolatum, up to 100 percent.
(7) White wax, up to 5 percent in combination with one or more other emollient agents included in the monograph.
(8) Yellow wax, up to 5 percent in combination with one or more other emollient agents included in the monograph.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.