Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol

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.