Label Changes for:
Peridex (chlorhexidine gluconate) Oral Rinse, 0.12 percent
January 2013
Changes have been made to the WARNINGS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2013
WARNINGS
- ..... Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. (SEE CONTRAINDICATIONS).
PATIENT INFORMATION
What to expect when using Peridex Chlorhexidine Gluconate 0.12% Oral Rinse
- If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhea, seek medical attention immediately. Peridex oral rinse should not be used by persons who have a sensitivity to it or its components.
