Label: KOLORZ - sodium fluoride aerosol, foam 

  • NDC Code(s): 10733-372-00
  • Packager: Medical Products Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 03/11

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

  • 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.

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  • WARNINGS

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


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

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

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  • 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

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  • PRINCIPAL DISPLAY PANEL

    kolorz Sixty Second Fluoride Foam Blue Raspberry

    image of can label

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  • INGREDIENTS AND APPEARANCE
    KOLORZ 
    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10733-372
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (Fluoride ion) SODIUM FLUORIDE 27.2 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SUCRALOSE  
    XYLITOL  
    SODIUM PHOSPHATE, MONOBASIC  
    BETAINE  
    POLOXAMER 407  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BERRY (Mixed Berry Flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10733-372-00 6 in 1 BOX
    1 125 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2007
    Labeler - Medical Products Laboratories, Inc. (002290302)
    Registrant - Medical Products Laboratories, Inc. (002290302)
    Establishment
    Name Address ID/FEI Business Operations
    Medical Products Laboratories, Inc. 002290302 analysis, manufacture, label, pack
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