Label: KOLORZ SIXTY SECOND FLUORIDE FOAM BLUE RASPBERRY- sodium fluoride aerosol, foam
KOLORZ SIXTY SECOND FLUORIDE FOAM CHERRY CHEESECAKE- sodium fluoride aerosol, foam
KOLORZ SIXTY SECOND FLUORIDE FOAM COTTON CANDY- sodium fluoride aerosol, foam
KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINT- sodium fluoride aerosol, foam

  • NDC Code(s): 25047-761-44, 25047-762-44, 25047-763-44, 25047-764-44
  • Packager: DMG AMERICA, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 1, 2021

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  • 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.

    Figure

  • 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.

  • 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.

  • EMERGENCY RESPONSE

    Call Infotrac 1-800-535-5053

    Made in USA

    Distributed by: DMG America LLC.
    242 South Dean Street
    Englewood, NJ 07631
    800-662-6383
    www.dmg-america.com
    Rev. 4/13

    RE-ORDER #766202

  • INSTRUCTIONS FOR USE

    kolorz®

    By DMG America
    Instructions For Use

    Kolorz Sixty Second Fluoride Foam

    Kolorz Neutral Fluoride Foam

    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.

    Figure

    Dosage and Administration:

    1. Shake can vigorously before each use. (Fig. 1)

      Figure

    2. 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. (Fig. 2)

      Figure

    3. Dry tooth surface and insert tray(s) in mouth.
    4. For Kolorz Sixty Second Fluoride Foam: Have patient bite down lightly but firmly for 1 to 4 minutes; For Kolorz Neutral Fluoride Foam: Have patient bite down lightly but firmly for 4 minutes.
    5. Remove tray(s) and have patient expectorate excess
    6. Instruct patient not to eat, drink, or rinse for at least 30 minutes after application.

    How Supplied: Both Kolorz Sixty Second Fluoride Foam and Kolorz Neutral Fluoride Foam are available in 4.4oz. (125g) cans and do not contain chlorofluorocarbon propellant.

    Caution: For professional use only. Federal U.S.A. Law prohibits dispensing without prescription.

    Warning: Contents under pressure. Do not puncture or incinerate. Store between 55-80° F. Keep from freezing.

    kolorz®

    Distributed by DMG America
    242 South Dean Street
    Englewood, NJ 07631 USA
    Tel: 201-894-5505
    Fax: 201-894-0213
    www.dmg-america.com

    395490 Rev. 11/13

  • PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Blue Raspberry

    Best Taste…
    Guaranteed!

    kolorz®

    Sixty
    Second
    Fluoride Foam
    Blue Raspberry

    APF Topical Fluoride
    Acidulated Phosphate Fluoride
    1.23% Fluoride Ion

    GLUTEN FREE!

    Contains
    XYLITOL

    CAUTION:
    For professional use only.

    Store at room temperature.

    Shake well before each use.

    NET WT. 4.4 OZ (125g)

    PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Blue Raspberry
  • PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cherry Cheesecake

    Best Taste…
    Guaranteed!

    kolorz®

    Sixty
    Second
    Fluoride Foam
    Cherry Cheesecake

    APF Topical Fluoride
    Acidulated Phosphate Fluoride
    1.23% Fluoride Ion

    GLUTEN FREE!

    Contains
    XYLITOL

    CAUTION:
    For professional use only.

    Store at room temperature.

    Shake well before each use.

    NET WT. 4.4 OZ (125g)

    PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cherry Cheesecake
  • PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cotton Candy

    Best Taste…
    Guaranteed!

    kolorz®

    Sixty
    Second
    Fluoride Foam
    Cotton Candy

    APF Topical Fluoride
    Acidulated Phosphate Fluoride
    1.23% Fluoride Ion

    GLUTEN FREE!

    Contains
    XYLITOL

    CAUTION:
    For professional use only.

    Store at room temperature.

    Shake well before each use.

    NET WT. 4.4 OZ (125g)

    PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cotton Candy
  • PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Triple Mint

    Best Taste…
    Guaranteed!

    kolorz®

    Sixty
    Second
    Fluoride Foam
    Triple Mint

    APF Topical Fluoride
    Acidulated Phosphate Fluoride
    1.23% Fluoride Ion

    GLUTEN FREE!

    Contains
    XYLITOL

    CAUTION:
    For professional use only.

    Store at room temperature.

    Shake well before each use.

    NET WT. 4.4 OZ (125g)

    PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Triple Mint
  • INGREDIENTS AND APPEARANCE
    KOLORZ SIXTY SECOND FLUORIDE FOAM   BLUE RASPBERRY
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-764
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.23 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRY (BLUE RASPBERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-764-44125 g in 1 CAN; Type 0: Not a Combination Product11/22/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER11/22/2006
    KOLORZ SIXTY SECOND FLUORIDE FOAM   CHERRY CHEESECAKE
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-762
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.23 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (CHERRY CHEESECAKE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-762-44125 g in 1 CAN; Type 0: Not a Combination Product11/22/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER11/22/2006
    KOLORZ SIXTY SECOND FLUORIDE FOAM   COTTON CANDY
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-763
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.23 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-763-44125 g in 1 CAN; Type 0: Not a Combination Product11/22/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER11/22/2006
    KOLORZ SIXTY SECOND FLUORIDE FOAM   TRIPLE MINT
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-761
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.23 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (TRIPLE MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-761-44125 g in 1 CAN; Type 0: Not a Combination Product11/22/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER11/22/2006
    Labeler - DMG AMERICA, LLC (106792427)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Products Laboratories, Inc.002290302MANUFACTURE(25047-761, 25047-762, 25047-763, 25047-764) , PACK(25047-761, 25047-762, 25047-763, 25047-764) , LABEL(25047-761, 25047-762, 25047-763, 25047-764)
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