[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR349.75]

[Page 274]
 
                        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. 349.75  Labeling of ophthalmic vasoconstrictor 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 
``redness reliever'' or ``vasoconstrictor (redness reliever)'' (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: ``Relieves redness of the 
eye due to minor eye irritations.''
    (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. 349.18:
    (1) ``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.''
    (2) ``If you have glaucoma, do not use this product except under the 
advice and supervision of a doctor.''
    (3) ``Overuse of this product may produce increased redness of the 
eye.''
    (4) ``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 to 2 drops in 
the affected eye(s) up to four times daily.

    Effective Date Note: At 65 FR 38428, June 21, 2000, Sec. 349.75 was 
amended by revising paragraph (c)(2) and by adding paragraph (c)(5), 
effective May 16, 2002. For the convenience of the user, the revised 
text is set forth as follows.

Sec. 349.75  Labeling of ophthalmic vasoconstrictor drug products.

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    (c)   
    (2) ``Ask a doctor before use if you have [in bold type] narrow 
angle glaucoma.''

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    (5) ``When using this product [in bold type] pupils may become 
enlarged temporarily.''

                                * * * * *