21 C.F.R. § 344.3   Definitions.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 344—TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart A—General Provisions

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§ 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° 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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