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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 346 - Anorectal Drug Products for over-the-Counter Human Use |
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Subpart B - Active Ingredients |
§ 346.16 - Analgesic, anesthetic, and antipruritic active ingredients.
Latest version.
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§ 346.16 Analgesic, anesthetic, and antipruritic active ingredients.
The active ingredient of the product consists of any of the following when used within the concentration range established for each ingredient:
(a) Camphor 0.1 to 3 percent.
(b) Juniper tar 1 to 5 percent.
(c) Menthol 0.1 to 1 percent.