Chlorhexidine

FDA Drug Profile

Drug Details

Generic Name
Chlorhexidine
Brand Names
N/A
Application Number
Sponsor
Medichem S.A.
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
CHLORHEXIDINE

Indications and Usage

INDICATIONS AND USAGE Chlorhexidine gluconate oral rinse, 0.12% 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, 0.12% 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, 0.12% 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 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 ) .