Label: GELATO APF- sodium fluoride gel

  • NDC Code(s): 68400-106-15
  • 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 04/15

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  • Active ingredient:                                                        Purpose:

    Fluoride Ion 1.23% ............................... Fluoride Treatment Gel

    Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

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  • Indications and usage:

    • A stable thixtropic fluoride treatment gel used to help prevent dental decay.
    • For professional office use only. This product is not intended for home or unsupervised consumer use.
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  • Warnings:

    • Keep out of reach of children.
    • Do not swallow. If product is accidentally swallowed in quantites greater than would normally occur with a treatment gel, seek medical help or contact a poison control center right away.
    • Read directions carefully before using.
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  • Dosage and administration:

    Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two 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 one minute (80% effectiveness) or four minutes (100% effectiveness).

    3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

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  • Other information:

    • Store at controlled room temperature 59° to 86°F (15° -30°C). Protect from freezing.
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  • Inactive ingredients:

    Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive.

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  • INGREDIENTS AND APPEARANCE
    GELATO APF 
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68400-106
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 5.6 g  in 454 g
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Water (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    May contain FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    May contain FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    May contain FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    May contain FD&C RED NO. 40 (UNII: WZB9127XOA)  
    May contain FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    May contain FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color red Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68400-106-15 454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/14/2012
    Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
    Establishment
    Name Address ID/FEI Business Operations
    Keystone Industries 014769301 manufacture(68400-106) , label(68400-106)
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