GELATO NEUTRAL PH DYE FREE MINT - sodium fluoride gel 
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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Inactive Ingredients

Flavor, Phosphoric Acid, Sodium Saccharine, Xylitol, Citric Acid, Sodium Benzoate, Water, Titanium Dioxide, Polysorbate 20, Xantham Gum, Magnesium Aluminum Silicate, Potassium Hydroxide.

Warnings

  • Keep out of reach of children.
  • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
  • This product contains a concentrated fluoride amount and is available by prescription only. It should be used under professional supervision.

Dosage and Administration

Shake lightly before use. This is a four minute topical fluoride gel for in-office patient use. It is normally used as a preventive caries treatment 2 times a year.


  1. After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into the mouth.
  2. Instruct patient to bite down lightly but firmly for FOUR MINUTES.
  3. Remove trays. Instruct patient to expectorate any exces gel and not to eat or drink for at least 30 minutes.

Indications and Usage

This is a prescription fluoride treatment gel used to help prevent dental decay.

Other Information

  • Store at controlled room temperature 50° - 86° F (15° - 30° C)
  • Protect from freezing

Active Ingredients

Sodium Fluoride 2%

Entire Label

GELATO NEUTRAL PH DYE FREE MINT 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68400-136
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHOSPHORIC ACID 
SACCHARIN SODIUM 
XYLITOL 
CITRIC ACID MONOHYDRATE 
SODIUM BENZOATE 
WATER 
TITANIUM DIOXIDE 
POLYSORBATE 20 
XANTHAN GUM 
MAGNESIUM ALUMINUM SILICATE 
POTASSIUM HYDROXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68400-136-15480 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/15/2010
Labeler - Deepak Products, inc. (124886743)
Establishment
NameAddressID/FEIBusiness Operations
Deepak Products, inc.124886743manufacture

Revised: 02/2010
 
Deepak Products, inc.