Chlorhexidine Gluconate 0.12% Oral Rinse
Drug Details
- Generic Name
- Chlorhexidine Gluconate 0.12% Oral Rinse
- Brand Names
- DASH Chlorhexidine Gluconate 0.12% Oral Rinse, Acclean Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine Gluconate 0.12% Oral Rinse
- Application Number
- ANDA074291
- Sponsor
- Natco Pharma USA LLC
- NDC Codes
- 10
- Dosage Forms
- LIQUID, SOLUTION
- Routes
- ORAL
- Active Ingredients
- CHLORHEXIDINE GLUCONATE
Indications and Usage
INDICATIONS AND USAGE: 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 .