[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: 21CFR349.50]

[Page 285]
 
                        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. 349.50  Labeling of ophthalmic drug products.


    (a) The word ``physician'' may be substituted for the word 
``doctor'' in any of the labeling statements in this part.
    (b) Where applicable, indications in this part applicable to each 
ingredient in the product may be combined to eliminate duplicative words 
or phrases so that the resulting information is clear and 
understandable. Other truthful and nonmisleading statements, describing 
only the indications for use that have been established and listed in 
this part, may also be used, as provided in Sec. 330.1(c)(2), subject 
to the provisions of section 502 of the act relating to misbranding and 
the prohibition in section 301(d) of the act against the introduction or 
delivery for introduction into interstate commerce of unapproved new 
drugs in violation of section 505(a) of the act.
    (c) The labeling of the product contains the following warnings, 
under the heading ``Warnings'':
    (1) For ophthalmic drug products packaged in multi-use containers. 
``To avoid contamination, do not touch tip of container to any surface. 
Replace cap after using.''
    (2) For ophthalmic drug products packaged in single-use containers. 
``To avoid contamination, do not touch tip of container to any surface. 
Do not reuse. Once opened, discard.''
    (3) For ophthalmic drug products containing mercury compounds used 
as a preservative. ``This product contains (name and quantity of 
mercury-containing ingredient) as a preservative. Do not use this 
product if you are sensitive to'' (select one of the following: 
``mercury'' or ``(insert name of mercury-containing ingredient) or any 
other ingredient containing mercury).''