Label: PURELIFE APF- sodium fluoride gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status:

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 December 18, 2017

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

  • Active Ingredient

    Fluoride Ion 1.23%.

    Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

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  • Purpose

    Fluoride Treatment Gel

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  • 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.
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  • 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.
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  • 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 try, 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.

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  • Other Information

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

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  • Inactive Ingredients

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

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  • INGREDIENTS AND APPEARANCE
    PURELIFE APF 
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68987-014
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 5.6 g  in 454 g
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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)  
    Product Characteristics
    Color pink Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68987-014-15 454 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/01/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 12/18/2012
    Labeler - PureLife Dental (828690904)
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