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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 348 - External Analgesic Drug Products for over-the-Counter Human Use |
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Subpart B - Active Ingredients |
§ 348.10 - Analgesic, anesthetic, and antipruritic active ingredients.
Latest version.
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§ 348.10 Analgesic, anesthetic, and antipruritic active ingredients.
The active ingredient of the product consists of any of the following within the specified concentration established for each ingredient:
(a) Male genital desensitizers.
(1) Benzocaine, 3 to 7.5 percent in a water-soluble base.
(2) Lidocaine in a metered spray with approximately 10 milligrams per spray.
(b) [Reserved]