[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR349.78]

[Page 287]
 
                        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 
 
                           Subpart C_Labeling
 
Sec.  349.78  Labeling of eyewash drug products.

    (a) Statement of identity. The labeling of the product identifies 
the product with one or more of the following terms: ``eyewash,'' ``eye 
irrigation,'' or ``eye irrigating solution.''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' one of the following phrases:
    (1) ``For'' (select one of the following: ``flushing,'' 
``irrigating,'' ``cleansing,'' ``washing,'' or ``bathing'') ``the eye to 
remove'' (select one or more of the following: ``loose foreign 
material,'' ``air pollutants (smog or pollen),'' or ``chlorinated 
water'').
    (2) ``For'' (select one of the following: ``flushing,'' 
``irrigating,'' ``cleansing,'' ``washing,'' or ``bathing'') ``the eye to 
help relieve'' (select one or more of the following: ``irritation,'' 
``discomfort,'' ``burning,'' ``stinging,'' ``smarting,'' or ``itching'') 
``by removing'' (select one or more of the following: ``loose foreign 
material,'' ``air pollutants (smog or pollen),'' or ``chlorinated 
water'').
    (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 all eyewash products:
    (1) ``If you experience eye pain, changes in vision, continued 
redness or irritation of the eye, or if the condition worsens or 
persists, consult a doctor.''
    (2) ``Obtain immediate medical treatment for all open wounds in or 
near the eyes.''
    (3) ``If solution changes color or becomes cloudy, do not use.''
    (d) Directions. The labeling of the product contains the following 
information under the heading ``Directions'':
    (1) For eyewash products intended for use with an eyecup. Rinse cup 
with clean water immediately before each use. Avoid contamination of rim 
and inside surfaces of cup. Fill cup half full and apply the cup to the 
affected eye, pressing tightly to prevent the escape of the liquid, and 
tilt the head backward. Open eyelids wide and rotate eyeball to ensure 
thorough bathing with the wash or lotion. Rinse cup with clean water 
after each use.
    (2) For eyewash products intended for use with a nozzle applicator. 
Flush the affected eye as needed, controlling the rate of flow of 
solution by pressure on the bottle.

[53 FR 7090, Mar. 4, 1988, as amended at 68 FR 7921, Feb. 19, 2003]