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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 344 - Topical Otic Drug Products for over-the-Counter Human Use |
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Subpart A - General Provisions |
§ 344.3 - Definitions.
Latest version.
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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]