United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1995_register executive 2010-09-25 article Part X Rules and Regulations D09002ee1be06481a D09002ee1be06491e United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing a final rule establishing a maximum concentration limit for alcohol (ethyl alcohol) as an inactive ingredient in over-the-counter (OTC) drug products intended for oral ingestion (0.5 percent alcohol for children under 6 years of age, 5 percent alcohol for children 6 to under 12 years of age, and 10 percent alcohol for anyone 12 years of age and over). This final rule also requires that the alcohol content be stated prominently and conspicuously on the principal display (front) panel of product labeling. FDA is issuing this final rule after considering recommendations from its Nonprescription Drugs Advisory Committee (NDAC) and public comments on the agency's notice of proposed rulemaking. This final rule defers action on alcohol limits for Aromatic Cascara Fluidextract, Cascara Sagrada Fluidextract, and orally ingested OTC homeopathic drug products. 60 FR 13590 https://www.govinfo.gov/app/details/FR-1995-03-13/95-6128 95-6128 fr13mr95-9 4160-01-F Docket No. 93N-0107 https://www.govinfo.gov/app/details/FR-1995-03-13/95-6128 https://www.govinfo.gov/content/pkg/FR-1995-03-13/html/95-6128.htm https://www.govinfo.gov/content/pkg/FR-1995-03-13/pdf/95-6128.pdf 6 p. 13590 13595 60 FR 13590 Title 21 Part 328 21 CFR Part 328 Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol; Federal Register Vol. 60, Issue RULE 95-6128 X DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 93N-0107 4160-01-F 95-6128 Final rule.

The Food and Drug Administration (FDA) is issuing a final rule establishing a maximum concentration limit for alcohol (ethyl alcohol) as an inactive ingredient in over-the-counter (OTC) drug products intended for oral ingestion (0.5 percent alcohol for children under 6 years of age, 5 percent alcohol for children 6 to under 12 years of age, and 10 percent alcohol for anyone 12 years of age and over). This final rule also requires that the alcohol content be stated prominently and conspicuously on the principal display (front) panel of product labeling. FDA is issuing this final rule after considering recommendations from its Nonprescription Drugs Advisory Committee (NDAC) and public comments on the agency's notice of proposed rulemaking. This final rule defers action on alcohol limits for Aromatic Cascara Fluidextract, Cascara Sagrada Fluidextract, and orally ingested OTC homeopathic drug products.

March 13, 1996. William E. Gilbertson, Center for Drug Evaluation and Research (HFD-810), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5000. Vol. 60, no. 48 Office of the Federal Register, National Archives and Records Administration 1995-03-13 continuing daily deposited born digital 253 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1995-03-13 P0b002ee180a83c9f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13mr95 https://www.govinfo.gov/app/details/FR-1995-03-13 https://www.govinfo.gov/content/pkg/FR-1995-03-13/pdf/FR-1995-03-13.pdf fdlp 13367 13611 DGPO 2010-09-25 2023-05-07 FR-1995-03-13 machine generated eng FR FR-1995-03-13 60 48