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.

----------

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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-500
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE56.76 mL  in 473 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
FD&C BLUE NO. 1 
SACCHARIN SODIUM 
POLYSORBATE 20 
POLOXAMER 407 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68400-500-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Labeler - Deepak Products, inc. (124886743)
Establishment
NameAddressID/FEIBusiness Operations
Deepak Products, inc.124886743manufacture

Revised: 04/2011
 
Deepak Products, inc.