[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: 21CFR349.70]

[Page 286]
 
                        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 C_Labeling
 
Sec. 349.70  Labeling of ophthalmic hypertonicity drug products.

    (a) Statement of identity. The labeling of the product contains the 
established name of the drug, if any, and identifies the product as a 
``hypertonicity'' (select one of the following: ``eye'' or 
``ophthalmic'') ``(insert dosage form, e.g., drops).''
    (b) Indications. The labeling of the product states, under the 
heading ``Indications,'' the following phrase: ``For the temporary 
relief of corneal edema.''
    (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. 349.16:
    (1) ``Do not use this product except under the advice and 
supervision of a doctor. 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) ``This product may cause temporary burning and irritation on 
being instilled into the eye.''
    (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'': Instill 1 or 2 drops in 
the affected eye(s) every 3 or 4 hours, or as directed by a doctor.