[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.63]

[Page 20]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 801--LABELING--Table of Contents
 
      Subpart C--Labeling Requirements for Over-the-Counter Devices
 
Sec. 801.63  Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.

    (a) All over-the-counter devices containing or manufactured with 
chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or 
any other class I substance designated by the Environmental Protection 
Agency (EPA) shall carry one of the following warnings:
    (1) The EPA warning statement:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    (2) The alternative statement:
    Note: The indented statement below is required by the Federal 
government's Clean Air Act for all products containing or manufactured 
with chlorofluorocarbons (CFC's) [or other class I substance, if 
applicable]:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF YOU 
HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT.
    (b) The warning statement shall be clearly legible and conspicuous 
on the product, its immediate container, its outer packaging, or other 
labeling in accordance with the requirements of 40 CFR part 82 and 
appear with such prominence and conspicuousness as to render it likely 
to be read and understood by consumers under normal conditions of 
purchase. This provision does not replace or relieve a person from any 
requirements imposed under 40 CFR part 82.

[61 FR 20101, May 3, 1996]