Chlorhexidine Gluconante
Drug Details
- Generic Name
- Chlorhexidine Gluconante
- Brand Names
- Denti-Care Denti-Rinse Chlorhexidine Gluconate Oral Rinse
- Application Number
- ANDA077789
- Sponsor
- Xttrium Laboratories, Inc.
- NDC Codes
- 1
- Dosage Forms
- LIQUID
- Routes
- DENTAL
- 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. Hypersensitivity and generalized allergic reactions have occurred; SEE CONTRAINDICATIONS.