FDA Proposes Rulings on Nasal Decongestants and Requests a Call-For-Data on Triclosan for Gingivitis Treatment

Information on this proposed ruling comes from the Federal Register under Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for OTC Human Use; Proposed Amendment of Final Monograph or OTC Nasal Decongestant Drug Products. The proposal summary recommends removing the indication "for the temporary relief of nasal congestion associated with sinusitis" and to prohibit the terms "sinusitis" and "associated with sinusitis" elsewhere on the labeling. The FDA also recently announced a call-for-data for safety and effectiveness of Triclosan 0.3% maximum, as an antigingivitis ingredient in dental pastes and oral rinses. Federal Register Vol. 69, No. 147, August 2, 2004. Federal Register Vol. 69, No. 128, July 6, 2004. Return to Top