[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: 21CFR801.61]

[Page 16-17]
 
                        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. 801.61  Statement of identity.

    (a) The principal display panel of an over-the-counter device in 
package form shall bear as one of its principal features a statement of 
the identity of the commodity.
    (b) Such statement of identity shall be in terms of the common name 
of the device followed by an accurate statement of the principal 
intended action(s) of the device. Such statement shall be placed in 
direct conjunction with the most prominent display of the name and shall 
employ terms descriptive of the principal intended action(s). The 
indications for use shall be included in the directions for use of the 
device, as required by section 502(f)(1)

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of the act and by the regulations in this part.
    (c) The statement of identity shall be presented in bold face type 
on the principal display panel, shall be in a size reasonably related to 
the most prominent printed matter on such panel, and shall be in lines 
generally parallel to the base on which the package rests as it is 
designed to be displayed.