[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.61]

[Page 34-35]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201--LABELING--Table of Contents
 
       Subpart C--Labeling Requirements for Over-the-Counter Drugs
 
Sec. 201.61  Statement of identity.

    (a) The principal display panel of an over-the-counter drug 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 established 
name of the drug, if any there be, followed by an accurate statement of 
the general

[[Page 35]]

pharmacological category(ies) of the drug or the principal intended 
action(s) of the drug. In the case of an over-the-counter drug that is a 
mixture and that has no established name, this requirement shall be 
deemed to be satisfied by a prominent and conspicuous statement of the 
general pharmacological action(s) of the mixture or of its principal 
intended action(s) in terms that are meaningful to the layman. Such 
statements shall be placed in direct conjunction with the most prominent 
display of the proprietary name or designation and shall employ terms 
descriptive of general pharmacological category(ies) or principal 
intended action(s); for example, ``antacid,'' ``analgesic,'' 
``decongestant,'' ``antihistaminic,'' etc. The indications for use shall 
be included in the directions for use of the drug, as required by 
section 502(f)(1) 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.