0.12% Chlorhexidine Gluconate

FDA Drug Profile — Major Oral Rinse

Drug Details

Generic Name
0.12% Chlorhexidine Gluconate
Brand Names
Major Oral Rinse
Application Number
ANDA077789
Sponsor
Cardinal Health 107, LLC
NDC Codes
3
Dosage Forms
RINSE
Routes
ORAL
Active Ingredients
CHLORHEXIDINE GLUCONATE

Indications and Usage

INDICATION Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

Warnings

WARNINGS The effect of chlorhexidine gluconate oral rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate oral rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE CONTRAINDICATIONS.