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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 5]
[CITE: 21CFR344.3]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 344 -- TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

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]

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