Gelato Fluoride Foam

Generic Name: sodium fluoride
Dosage Form: aerosol, foam

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.

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

Do not swallow. Keep out of reach of children. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture on incinerate container. Do not spray toward open flame. For professional use only.

Distilled water, Polaxamer, Triethanolamine, Phosphoric Acid, Sodium Saccharine, Sodium Laureth Sulfate, Hydrofluoric Acid, Xylitol, Potassium Hydroxide, Propellant A31.

  • Store at controlled room temperature 59-86 F (15-30 C)
  • Protect from freezing


GELATO FLUORIDE 
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68400-112
Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1.5375 g  in 125 g
Inactive Ingredients
Ingredient Name Strength
WATER  
POLOXAMER 407  
TROLAMINE  
PHOSPHORIC ACID  
SACCHARIN SODIUM  
SODIUM BENZOATE  
SODIUM LAURETH SULFATE  
HYDROFLUORIC ACID  
XYLITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68400-112-12 125 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/02/2012
Labeler - Deepak Products, inc. (124886743)
Establishment
Name Address ID/FEI Operations
Deepak Products, inc. 124886743 manufacture
Revised: 02/2012
 
Deepak Products, inc.



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