Label: KOLORZ- sodium fluoride aerosol, foam

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Updated March 11, 2011

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  • DOSAGE & ADMINISTRATION

    Dosage and Administration
    Shake can vigorously before each use. Turn can completely upside down to dispense. Point can towards fluoride applicator tray and slowly press the nozzle to fill tray. Use one press per arch, as foam will expand slightly to fill the tray. Dry tooth surface and insert tray(s) in mouth. Have patient bite down lightly but firmly for 1 to 4 minutes. Remove tray(s) and have patient expectorate excess. Instruct patient not to eat, drink, or rinse for at least 30 minutes after application.

    Instructions For Use
    The first time you dispense from a new bottle, gently lift upward on the nozzle to break the protective shipping tab (thin plastic tab located adjacent to "trigger"). If this tab is not broken, there could be an initial surge of foam from the dispenser.

    CONTAINS
    Sodium Fluoride in a proprietary acidulated phosphate flavored foam base. 1.23% Fluoride Ion is available from 2.72% Sodium Fluoride. Does not contain chlorofluorocarbon propellant. Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten free.

  • WARNINGS

    WARNING Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 55-80 F. Keep from freezing.
  • PRECAUTIONS


    CAUTION
    For professional use only. Federal U.S.A. Law prohibits dispensing without prescription. Shake well before each use.
  • HOW SUPPLIED

    How Supplied
    Kolorz Sixty Second Fluoride Foam is available in 4.4 oz. (125g) can and do not contain chlorofluorocarbon propellant.

  • INDICATIONS & USAGE

    INDICATIONS
    For the topical application of fluoride to aid in the protection against dental caries. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.

    image of package insert

  • PRINCIPAL DISPLAY PANEL

    kolorz Sixty Second Fluoride Foam Triple Mint

    image of can label

  • INGREDIENTS AND APPEARANCE
    KOLORZ 
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10733-357
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE27.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    BETAINE (UNII: 3SCV180C9W)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINT (Peppermint Oil) , SPEARMINT (Spearmint Oil) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10733-357-006 in 1 BOX
    1125 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2007
    Labeler - Medical Products Laboratories, Inc. (002290302)
    Registrant - Medical Products Laboratories, Inc. (002290302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories, Inc.002290302analysis, manufacture, label, pack
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