Label: GELATO NEUTRAL PH- sodium fluoride gel

  • NDC Code(s): 68400-114-15
  • Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Updated April 22, 2024

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  • Active Ingredient:

    Sodium Fluoride 2%

  • Purpose:

    Fluoride Treatment Gel

  • 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 Conrol Center right away.
    • Read directions carefully before using.
  • Dosage and Administration:

    Shake well before use. This is a 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 four minutes.

    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, Potassium Hydroxide, 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.

  • PRINCIPAL DISPLAY PANEL

    LB.Gelato Neutral PH Sodium Fluoride Gel.jpg

  • INGREDIENTS AND APPEARANCE
    GELATO NEUTRAL PH 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68400-114
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION4.086 g  in 454 g
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68400-114-15454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2013
    Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
    Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.014769301manufacture(68400-114) , label(68400-114)
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