[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR349.14]

[Page 284]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 349_OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE--Table of Contents
 
                      Subpart B_Active Ingredients
 
Sec. 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.