Antiperspirant drug products for over-the-counter human use; final monograph. Final rule

Fed Regist. 2003 Jun 9;68(110):34273-93.


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.

MeSH terms

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


  • Aluminum Compounds
  • Deodorants
  • Nonprescription Drugs