[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: 21CFR344.3]

[Page 259]
 
                        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 A--General Provisions
 
Sec. 344.3  Definitions.

    As used in this part:
    (a) Anhydrous glycerin. An ingredient that may be prepared by 
heating glycerin U.S.P. at 150 deg. C for 2 hours to drive off the 
moisture content.
    (b) Earwax removal aid. A drug used in the external ear canal that 
aids in the removal of excessive earwax.
    (c) Water-clogged ears. The retention of water in the external ear 
canal, thereby causing discomfort and a sensation of fullness or hearing 
impairment.
    (d) Ear drying aid. A drug used in the external ear canal to help 
dry water-clogged ears.

[51 FR 28660, Aug. 8, 1986, as amended at 65 FR 48905, Aug. 10, 2000]