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Fed Regist ; 68(110): 34273-93, 2003 Jun 09.
Article in English | MEDLINE | ID: mdl-12795305

ABSTRACT

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) antiperspirant drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, issued as a tentative final monograph (TFM), and all new data and information on antiperspirant drug products that have come to the agency's attention.


Subject(s)
Aluminum Compounds/adverse effects , Deodorants/classification , Drug Labeling/legislation & jurisprudence , Nonprescription Drugs/classification , Animals , Consumer Product Safety , Drug Approval/legislation & jurisprudence , Humans , Legislation, Drug , Toxicity Tests/veterinary , United States , United States Food and Drug Administration
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