GroundRules
21 CFR 349.14: Ophthalmic emollients.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 349—OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart B—Active Ingredients
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON