Label: ZAP NEUTRAL- sodium fluoride gel

  • NDC Code(s): 24794-108-16
  • Packager: Crosstex International Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated January 19, 2022

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  • Active Ingredient:

    Sodium Fluoride 2% (0.9% Fluoride Ion)

  • Purpose:

    Anticaries Treatment.

  • Indications and Usage:

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

  • 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.
    • This product contains a concentrated fluoride amount and is available by prescription only. It should be used under professional supervision.
  • Dosage and Administration:

    Shake lightly before use. This is a four minute topical fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

    1. After thorough prophylaxsis, 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 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, FD&C Green #3, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

  • PRINCIPAL DISPLAY PANEL

    LB.ZAP APF_Neutral Mint Rev 5.jpg

  • INGREDIENTS AND APPEARANCE
    ZAP NEUTRAL 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24794-108
    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
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    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)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24794-108-16454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/14/2012
    Labeler - Crosstex International Inc. (057728685)
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