Label: GELATO NEUTRAL PH - sodium fluoride aerosol, foam 

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/11

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

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

    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.

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  • INACTIVE INGREDIENT

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

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  • STORAGE AND HANDLING

    • Store at controlled room temperature 59-86 F (15-30 C)
    • Protect from freezing
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  • INGREDIENTS AND APPEARANCE
    GELATO NEUTRAL PH 
    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68400-138
    Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.5 g  in 125 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POLOXAMER 407  
    DECYL GLUCOSIDE  
    SODIUM LAURETH SULFATE  
    TROLAMINE  
    PHOSPHORIC ACID  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    XYLITOL  
    HYDROFLUORIC ACID  
    POTASSIUM HYDROXIDE  
    DMDM HYDANTOIN  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68400-138-04 125 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 08/11/2011
    Labeler - Deepak Products, inc. (124886743)
    Establishment
    Name Address ID/FEI Business Operations
    Deepak Products, inc. 124886743 manufacture
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