Label: GELATO APF- sodium fluoride aerosol, foam 

  • NDC Code(s): 68400-134-12
  • Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/13

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

  • Active Ingredient:

    1.23% Fluoride Ion. Available from 1.81% Sodium Fluoride and Hydrofluoric Acid.

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  • Purpose:

    Fluoride Preventative Treatment Foam.

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  • Indications and Usage:

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

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  • 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 or incinerate container. Do not spray toward open flame. For Professional Use Only.

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  • Instructions for Use:

    • Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
    • To dispense, invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray).
    • Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave tray in contact with the teeth between 1-4 minutes.
    • Use a saliva ejector during treatment to minimize ingestion of product.
    • Remove tray(s) and have patient expectorate.
    • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.
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  • Inactive Ingredients:

    Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharin, Triethanolamine, Xylitol, Propellant A31.

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  • Other Information:

    Store at controlled room temperature 59° - 86°F (15°-30°C).

    Protect from freezing.

    Shake well before each use.

    Invert can completely and depress nozzle to dispense.

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  • INGREDIENTS AND APPEARANCE
    GELATO APF 
    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68400-134
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5375 g  in 125 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    PHOSPHORIC ACID  
    POLOXAMER 407  
    SODIUM BENZOATE  
    SODIUM LAURETH-3 SULFATE  
    SACCHARIN SODIUM  
    TROLAMINE  
    XYLITOL  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor COTTON CANDY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68400-134-12 125 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/27/2013
    Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (078654194)
    Establishment
    Name Address ID/FEI Business Operations
    Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 078654194 manufacture(68400-134), label(68400-134)
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