What Is Chlorhexidine?

A chlorhexidine gluconate 4% antiseptic solution label posted on DailyMed lists its uses as a surgical hand scrub that significantly reduces microorganisms on the hands and forearms, a healthcare personnel handwash, patient preoperative skin preparation, and skin wound and general cleansing. A prescription chlorhexidine gluconate oral rinse label says the rinse is indicated for use between dental visits, as part of a professional program, to treat gingivitis marked by redness and swelling of the gums, including bleeding on probing.

Allergic reactions can be serious. The 4% solution label carries an allergy alert saying the product may cause a severe allergic reaction, with symptoms that may include wheezing or difficulty breathing, shock, facial swelling, hives and rash, and says to stop use and seek medical help right away if a reaction occurs. The oral rinse label says anaphylaxis and other serious allergic reactions have been reported during postmarketing use of dental products containing chlorhexidine.

The oral rinse label says it can stain oral surfaces such as tooth surfaces, restorations and the top of the tongue, and that in clinical testing 56% of users had a measurable increase in stain on the front teeth compared with 35% of control users after six months, with 15% developing heavy stain compared with 1% of controls. In its December 2017 final rule on health care antiseptics, the FDA said chlorhexidine gluconate continues to be ineligible for evaluation under the OTC Drug Review for use as a health care antiseptic, so drug products containing it for that use require approval under a new drug application or abbreviated new drug application before marketing.