Rinse

FDA Drug Profile — StellaLife VEGA Oral Care Rinse

Drug Details

Generic Name
Rinse
Brand Names
StellaLife VEGA Oral Care Rinse
Application Number
Sponsor
StellaLife, Inc.
NDC Codes
2
Dosage Forms
RINSE
Routes
DENTAL
Active Ingredients
AZADIRACHTA INDICA BARK, CALENDULA OFFICINALIS FLOWER, ECHINACEA PURPUREA, PLANTAGO MAJOR

Indications and Usage

INDICATION 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 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.