NRG APF (SODIUM FLUORIDE) GEL [IQ DENTAL SUPPLY, LLC]

NRG APF (SODIUM FLUORIDE) GEL [IQ DENTAL SUPPLY, LLC]
PDF | XML

NDC 42756-1111-7
Set ID df997bad-a768-4208-aa25-132ca5ad8bb6
Category HUMAN PRESCRIPTION DRUG LABEL
Packager IQ Dental Supply, LLC
Generic Name
Product Class
Product Number
Application Number
  • Active Ingredient:                                          Purpose:

    Fluoride Ion 1.23%..............................................Flouride 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 Use Only. This product is not intended for home or unsupervised 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 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 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:

    Store at controlled room temperature 59° to 86°F (15°-30°C).

    Protect from freezing.

  • Inactive Ingredients:

    Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

  • PRINCIPAL DISPLAY PANEL

    NRGAPFGELCH

  • INGREDIENTS AND APPEARANCE
    NRG APF 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42756-1111
    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)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    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)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42756-1111-7454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2013
    Labeler - IQ Dental Supply, LLC (800349763)

Related Drugs