[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR344.52]

[Page 268-269]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 344_TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of 
 
                           Subpart C_Labeling
 
Sec.  344.52  Labeling of ear drying aid drug products.

    (a) Statement of identity. The labeling of the product contains the 
established name of the drug, if any, and identifies the product as an 
``ear drying aid.''
    (b) Indications. The labeling of the product states, under the 
heading ``Use,'' the following: ``dries water in the ears'' (optional, 
which may be followed by: ``and relieves water-clogged ears'') (which 
may be followed by any or all of the following: ``after: [bullet] \1\ 
swimming [bullet] showering [bullet] bathing [bullet] washing the 
hair''). Other truthful and nonmisleading statements, describing only 
the indications for use that have been established and listed in 
paragraph (b) of this section, may also be used, as provided in Sec.  
330.1(c)(2) of this chapter, subject to the provisions of section 502 of 
the Federal Food, Drug, and Cosmetic Act (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.
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    \1\ See Sec.  201.66(b)(4) of this chapter.
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    (c) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'':

[[Page 269]]

    (1) ``Flammable [in bold type]: Keep away from fire or flame.''
    (2) ``Do not use [in bold type] in the eyes.''
    (3) ``Ask a doctor before use if you have [in bold type] [bullet] 
ear drainage or discharge [bullet] pain, irritation, or rash in the ear 
[bullet] had ear surgery [bullet] dizziness.''
    (4) ``Stop use and ask a doctor if [in bold type] irritation (too 
much burning) or pain occurs.''
    (d) Directions. The labeling of the product contains the following 
statement under the heading ``Directions'': [optional, bullet] ``apply 4 
to 5 drops in each affected ear.''

[65 FR 48905, Aug. 10, 2000]