Label: FLOAM TOPICAL FLOAM FLUORIDE- sodium fluoride aerosol, foam

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

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Drug Label Information

Updated May 17, 2017

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  • Recommended use:

    A topical anticaries preparation for professional dental use only.

  • PURPOSE

    1.23% fluoride ion (from 1.69% sodium fluoride and 0.5% hydrogen fluoride) in a flavored base at pH 4.

  • Medicinal ingredients:

    1.23% fluoride ion.

  • Non-medicinal ingredients:

    Water, glycerin, cocamidopropyl betaine, xylitol, phosphoric acid, flavouring agents, xanthan gum, polysorbate 20, poloxamer 407, sodium saccharin, PVP, sodium benzoate

  • Directions:

    1. Use after thorough prophylaxis. 2. Shake prior to dispensing. 3. Place nozzle tip to applicator floor and press down on trigger to dispense foam. NOTE: Foam will expand to fill tray. 4. Immediately place trays in mouth and have patient bite down lightly for one minute. 5. Remove trays and have patient expectorate excess.

  • Warning:

    Do not eat, drink, or rinse for 30 minutes after treatment. Do not puncture or incinerate container or store at temperatures over 50°C. Do not use in presence of open flame or spark. Contents under pressure; do not place in hot water or near any sources of heat.

  • KEEP OUT OF REACH OF CHILDREN

    Kep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    Floam

  • INGREDIENTS AND APPEARANCE
    FLOAM TOPICAL FLOAM FLUORIDE 
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-1120
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.732 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ) 1.039 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 14.96 g  in 100 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.609 g  in 100 g
    XANTHAN GUM (UNII: TTV12P4NEE) 0.798 g  in 100 g
    POLOXAMER 407 (UNII: TUF2IVW3M2) 2.991 g  in 100 g
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.1 g  in 100 g
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.199 g  in 100 g
    XYLITOL (UNII: VCQ006KQ1E) 3.99 g  in 100 g
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 4.985 g  in 100 g
    POVIDONE (UNII: FZ989GH94E) 0.1 g  in 100 g
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) 2.493 g  in 100 g
    WATER (UNII: 059QF0KO0R) 66.004 g  in 100 g
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorBERRY, MINT, ORANGE, STRAWBERRY, BUBBLE GUM, GRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61508-1120-1125 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/06/2017
    Labeler - Germiphene Corporation (206412512)
    Establishment
    NameAddressID/FEIBusiness Operations
    Germiphene Corporation206412512manufacture(61508-1120)
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