[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR349.65]

[Page 272]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 349--OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                           Subpart C--Labeling
 
Sec. 349.65  Labeling of ophthalmic emollient drug products.

    (a) Statement of identity. The labeling of the product contains the 
established name of the drug(s), if any, and identifies the product as a 
``lubricant'' or ``emollient (lubricant)'' (select one of the following: 
``eye'' or ``ophthalmic'') ``(insert dosage form, e.g., ointment).''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' one or more of the following phrases:
    (1) ``For the temporary relief of burning and irritation due to 
dryness of the eye.''
    (2) ``For the temporary relief of discomfort due to minor 
irritations of the eye or to exposure to wind or sun.''
    (3) ``For use as a protectant against further irritation or to 
relieve dryness of the eye.''
    (4) ``For use as a lubricant to prevent further irritation or to 
relieve dryness of the eye.''
    (c) Warnings. In addition to the warnings in Sec. 349.50, the 
labeling of the product contains the following warnings under the 
heading ``Warnings'' for products containing any ingredient identified 
in Sec. 349.14: ``If you experience eye pain, changes in vision, 
continued redness or irritation of the eye, or if the condition worsens 
or persists for more than 72 hours, discontinue use and consult a 
doctor.''
    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions'': Pull down the lower lid of 
the affected eye and apply a small amount (one-fourth inch) of ointment 
to the inside of the eyelid.