Label: GELATO NEUTRAL PH- 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 August 11, 2011

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  • INDICATIONS & 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 on incinerate container. Do not spray toward open flame. For professional use only.

  • INACTIVE INGREDIENT

    Distilled water, Polaxamer, Triethanolamine, Phosphoric Acid, Sodium Saccharine, Sodium Laureth Sulfate, Hydrofluoric Acid, Xylitol, Potassium Hydroxide, Propellant A31.

  • STORAGE AND HANDLING

    • Store at controlled room temperature 59-86 F (15-30 C)
    • Protect from freezing
  • PRINCIPAL DISPLAY PANEL

    Entire Label
  • INGREDIENTS AND APPEARANCE
    GELATO NEUTRAL PH 
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68400-138
    Route of AdministrationDENTAL, TOPICAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.5 g  in 125 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68400-138-04125 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/11/2011
    Labeler - Deepak Products, inc. (124886743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deepak Products, inc.124886743manufacture
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