Label: PURELIFE APF- sodium fluoride aerosol, foam

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

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Drug Label Information

Updated May 14, 2014

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  • Active Ingredient:

    1.23% Fluoride Ion.

    Available from 1.81% Sodium Fluoride and Hydrofluoric Acid.

  • Purpose:

    Fluoride Preventative Treatment Foam.

  • Indications and Usage:

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

  • Warnings:

    Do not swallow. Keep out of reach of children. Contents under pressure. Do not place in hot water or near radiators, stoves, or other sources of heat. Do not puncture or incinerate container. Do not spray toward open flame. For Professional Use Only.

  • Instructions for Use

    • Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
    • To dispense, invert the can completely upside down. Slowly depress nozzle to dispense foam into fluoride tray (foam will expand slightly higher than the tray).
    • Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth for 1-4 minutes.
    • Use a saliva ejector during treatment to minimize ingestion of the product.
    • Remove tray(s) and have patient expectorate.
    • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.
  • Inactive Ingredients

    Distilled Water, Flavor, Hydrofluoric Acid, Isobutane Propane Propellant, Phosphoric Acid, Poloxamer, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharin, Triethanolamine, Xylitol.

  • Other Information:

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

    Protect from freezing.

  • PRINCIPAL DISPLAY PANEL

    PLFoamCherry

  • INGREDIENTS AND APPEARANCE
    PURELIFE APF 
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68987-021
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5375 g  in 125 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68987-021-12125 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/27/2013
    Labeler - PureLife Dental (828690904)
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