21 C.F.R. § 349.14 Ophthalmic emollients.

Title 21 - Food and Drugs

Title 21: Food and Drugs
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.

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