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21CFR344.3

§ 344.3 Definitions.

Regulation Text

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.

Authority

21 U.S.C. 321,351,352,353,355,360,371.

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21CFR344.3 — § 344.3 Definitions. | CFR Explorer | BioRegHub