Gelato Chlorhexidine Rinse

Generic Name: chlorhexidine gluconate

Dosage Form: oral rinse
Gelato Chlorhexidine Distilled Water, Glycerin, Polysorbate 20, Poloxamer 407, Sodium Saccharin, Mint Flavor, FD and C Blue #1

The effect of Chlohexidrine Gluconate Oral Rinse on periodontitis has not been determined. An increase in supragingival calculus was not noted in clinical testing in chlohexidine 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 occured. read CONTRAINDICATIONS indicated on the insert inside the box.

To open, press down while turning cap. To seal, turn until cap clicks and is tight. Fill dosage cup to the fill like (150ml). Swish in your mouth undiluted for 30 seconds, the spit out. Use after breakfast and before bedtime. Or, use as prescribed by your dentist.

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. For patients having coexisting gingivitis and periodontitis, read PRECAUTIONS indicated on the insert inside the box.

Store at controlled room temperature 68-77F (20-25C). Protect from freezing.

0.12% Chlorhexidine Gluconate

Antigingivitis

GELATO CHLOROHEXIDINE  chlorhexidine gluconate  rinse

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68400-500 Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 56.76 mL  in 473 mL

Inactive Ingredients Ingredient Name Strength Water   Glycerin   FD&C BLUE NO. 1   SACCHARIN SODIUM   POLYSORBATE 20   POLOXAMER 407

Product Characteristics Color      Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68400-500-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/31/2010

Labeler - Deepak Products, inc. (124886743)

Establishment
Name	Address	ID/FEI	Operations
Deepak Products, inc.		124886743	manufacture

Revised: 04/2011Deepak Products, inc.

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Compare Gelato Chlorhexidine Rinse with other medications

• Gingivitis
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