Label: GELATO APF- sodium fluoride gel

  • NDC Code(s): 68400-109-15
  • 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

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.

Drug Label Information

Updated January 11, 2019

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

  • Active ingredient:                                                     Purpose:

    Fluoride Ion 1.23%............................ Fluoride Treatment Gel
    Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

  • Indications and usage:

    • A stable thixotropic 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.
  • 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.
    • Read directions carefully before using.
  • 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 twice 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.

  • Other information:

    • Do not store above 25°C/77°F. Do not freeze.

  • Inactive ingredients:

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

  • PRINCIPAL DISPLAY PANEL

    LB.Gelato APF Gel_generic_R2.jpg

  • INGREDIENTS AND APPEARANCE
    GELATO APF 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68400-109
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION5.6 g  in 454 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68400-109-15454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/14/2012
    Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Keystone Industries014769301manufacture(68400-109) , label(68400-109)