[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR344.50]

[Page 260]
 
                        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 Contents
 
                           Subpart C--Labeling
 
Sec. 344.50  Labeling of earwax removal 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 
``earwax removal aid.''
    (b) Indication. The labeling of the product states, under the 
heading ``Indication,'' the following: ``For occasional use as an aid 
to'' (which may be followed by: ``soften, loosen, and'') ``remove 
excessive earwax.'' Other truthful and nonmisleading statements, 
describing only the indications for use that have been established and 
listed in this paragraph (b), 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) Warnings. The labeling of the product contains the following 
warnings under the heading ``Warnings'':
    (1) ``Do not use if you have ear drainage or discharge, ear pain, 
irritation, or rash in the ear or are dizzy; consult a doctor.''
    (2) ``Do not use if you have an injury or perforation (hole) of the 
ear drum or after ear surgery unless directed by a doctor.''
    (3) ``Do not use for more than 4 days; if excessive earwax remains 
after use of this product, consult a doctor.''
    (4) ``Avoid contact with the eyes.''
    (d) Directions. The labeling of the product contains the following 
statement under the heading ``Directions'': FOR USE IN THE EAR ONLY. 
Adults and children over 12 years of age: tilt head sideways and place 5 
to 10 drops into ear. Tip of applicator should not enter ear canal. Keep 
drops in ear for several minutes by keeping head tilted or placing 
cotton in the ear. Use twice daily for up to 4 days if needed, or as 
directed by a doctor. Any wax remaining after treatment may be removed 
by gently flushing the ear with warm water, using a soft rubber bulb ear 
syringe. Children under 12 years of age: consult a doctor.

[51 FR 28660, Aug. 8, 1986; 52 FR 7830, Mar. 13, 1987; 65 FR 48905, Aug. 
10, 2000]