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Name:Gelato Chlorohexidine
Manufacturer:Deepak Products, Inc.
Category:Prescription Marketed Drugs


Gelato Chlorhexidine

GELATO CHLOROHEXIDINE  - chlorhexidine gluconate rinse 
Deepak Products, inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

Image of label

GELATO CHLOROHEXIDINE 
chlorhexidine gluconate rinse
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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
# Item Code Package Description Multilevel Packaging
1 NDC: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: 04/2011 Deepak Products, inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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