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FDA: Some skin antiseptic product labels to incorporate allergy warnings

February 16, 2017 Rare but serious allergic reactions have resulted from the use of skin antiseptic products containing chlorhexidine gluconate, the U.S. Food and Drug Administration said in a safety announcement Feb. 2.

The FDA said it is asking manufacturers of over-the-counter skin antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels because, although rare, the number of reports of serious allergic reactions to these products has increased over the last several years.

Chlorhexidine gluconate is available in over-the-counter products to clean and prepare skin before surgery and before injections in order to help reduce bacteria that can potentially cause skin infections, according to the FDA. The product comes in the form of solutions, washes, sponges and swabs under several different brand names and as generics.

Chlorhexidine gluconate is also available as a prescription mouthwash to treat gingivitis and as a prescription oral chip to treat periodontal disease. Allergy warnings already appear in the labels for these products.

Health care professionals should ask patients if they have ever had an allergic reaction to any antiseptic before recommending or prescribing a chlorhexidine gluconate product, the FDA said.

For more information on this and other safety alerts related to dentistry, visit ADA.org/safetyalerts.