The term ingredient applies to any substance in the drug, whether added to the formulation as a single substance or in admixture with other substances.


21 CFR § 201.10

Scoping language

The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and such statements that are specifically required for certain ingredients by the act or regulations in this chapter.

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