Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 349.14 - Ophthalmic emollients.

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.

source: 53 FR 7090, Mar. 4, 1988, unless otherwise noted.
cite as: 21 CFR 349.14