Gelato Neutral Sodium Fluoride Gel

Generic Name: sodium fluoride
Dosage Form: gel

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.

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.

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  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%


GELATO NEUTRAL PH DYE FREE MINT 
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68400-136
Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
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     
Shape Size
Flavor MINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68400-136-15 480 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/15/2010
Labeler - Deepak Products, inc. (124886743)
Establishment
Name Address ID/FEI Operations
Deepak Products, inc. 124886743 manufacture
Revised: 02/2010
 
Deepak Products, inc.



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