Label: ZAP APF- sodium fluoride gel

  • NDC Code(s): 24794-107-16
  • Packager: Crosstex International 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 21, 2022

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  • Active Ingredient:

    Fluoride Ion 1.23%. A stable thixotropic gel providing 1.23% fluoride ion. Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

  • Purpose:

    Anticaries Treatment.

  • Indications and Usage:

    This is a prescription fluoride treatment gel used to help prevent dental decay.
    • For Professional 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 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 of 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, Xanthan Gum, Xylitol.

  • PRINCIPAL DISPLAY PANEL

    ZAP_APF_dyefree_mint.jpg

  • INGREDIENTS AND APPEARANCE
    ZAP APF 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:24794-107
    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)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (Dye Free) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24794-107-16454 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)