Section 412 of Title IV of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act), signed into law by President Clinton on November 21, 1997, amended section 502(e) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 352(e)(1)) to require that the established name and quantity (or, if determined to be appropriate, the proportion) of each active ingredient appear on the label of all over-the-counter (OTC) drug products intended for human use.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
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All comments should be identified with the title of the guidance.