Label: KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE- sodium fluoride gel
KOLORZ SIXTY SECOND FLUORIDE PINA COLADA- sodium fluoride gel
KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT- sodium fluoride gel
KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY- sodium fluoride gel
KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY- sodium fluoride gel

  • NDC Code(s): 25047-771-16, 25047-772-16, 25047-773-16, 25047-774-16, view more
    25047-775-16
  • Packager: DMG AMERICA, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated March 28, 2019

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  • INDICATIONS

    For topical application of fluoride to aid in the protection against dental caries.

  • DOSAGE & ADMINISTRATION

    Fill fluoride tray(s) 1/3 full with gel. Dry tooth surface and insert tray(s) in mouth. Have patient bite down for 60 seconds (or up to 4 minutes). Slight chewing motion provides interproximal coverage. Remove tray(s) and have patient expectorate excess gel. Advise patient not to eat, drink or rinse for 30 minutes.

  • CONTAINS

    Sodium Fluoride in a proprietary acidulated phosphate flavored gel base. 1.23% Fluoride Ion from 2.72% Sodium Fluoride.

    Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten Free.

  • WARNING

    Keep out of reach of children. Do not swallow. If dosage or less than 100mg is ingested, contact poison control.

  • STORAGE AND HANDLING

    Store between 68-77° F. Keep from freezing.

  • SPL UNCLASSIFIED SECTION

    Contains FD&C Blue #1.

  • EMERGENCY RESPONSE

    Call Infotrac 1-800-535-5053

  • SPL UNCLASSIFIED SECTION

    Made in USA

    Distributed by :DMG America LLC, 242 South Dean Street
    Englewood, NJ 07631, 800-662-6383
    www.dmg-america.com
    Rev. 4/09

    RE-ORDER #777304
    392415

  • PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cherry Cheesecake

    Best Taste...
    Guaranteed!

    kolorz®

    Sixty
    Second
    Fluoride Gel
    Cherry Cheesecake

    APF Topical Fluoride
    Acidulated Phosphate Fluoride
    1.23% Fluoride Ion

    GLUTEN FREE!

    Contains
    XYLITOL

    CAUTION:
    For professional use only.

    Shake well before each use.

    NET WT. 16 OZ (480ml)

    PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cherry Cheesecake
  • PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Piña Colada

    Best Taste...
    Guaranteed!

    kolorz®

    Sixty
    Second
    Fluoride Gel
    Piña Colada

    APF Topical Fluoride
    Acidulated Phosphate Fluoride
    1.23% Fluoride Ion

    GLUTEN FREE!

    Contains
    XYLITOL

    CAUTION:
    For professional use only.

    Shake well before each use.

    NET WT. 16 OZ (480ml)

    PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Piña Colada
  • PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Triple Mint

    Best Taste...
    Guaranteed!

    kolorz®

    Sixty
    Second
    Fluoride Gel
    Triple Mint

    APF Topical Fluoride
    Acidulated Phosphate Fluoride
    1.23% Fluoride Ion

    GLUTEN FREE!

    Contains
    XYLITOL

    CAUTION:
    For professional use only.

    Shake well before each use.

    NET WT. 16 OZ (480ml)

    PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Triple Mint
  • PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Blue Raspberry

    Best Taste...
    Guaranteed!

    kolorz®

    Sixty
    Second
    Fluoride Gel
    Blue Raspberry

    APF Topical Fluoride
    Acidulated Phosphate Fluoride
    1.23% Fluoride Ion

    GLUTEN FREE!

    Contains
    XYLITOL

    CAUTION:
    For professional use only.

    Shake well before each use.

    NET WT. 16 OZ (480ml)

    PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Blue Raspberry
  • PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cotton Candy

    Best Taste...
    Guaranteed!

    kolorz®

    Sixty
    Second
    Fluoride Gel
    Cotton Candy

    APF Topical Fluoride
    Acidulated Phosphate Fluoride
    1.23% Fluoride Ion

    GLUTEN FREE!

    Contains
    XYLITOL

    CAUTION:
    For professional use only.

    Shake well before each use.

    NET WT. 16 OZ (480ml)

    PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cotton Candy
  • INGREDIENTS AND APPEARANCE
    KOLORZ SIXTY SECOND FLUORIDE   CHERRY CHEESECAKE
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-772
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (CHERRY CHEESECAKE) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-772-16480 mL in 1 BOTTLE; 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   PINA COLADA
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-775
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPINEAPPLE (PIÑA COLADA) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-775-16480 mL in 1 BOTTLE; 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   TRIPLE MINT
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-771
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (TRIPLE MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-771-16480 mL in 1 BOTTLE; 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   BLUE RASPBERRY
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-774
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorRASPBERRY (BLUE RASPBERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-774-16480 mL in 1 BOTTLE; 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   COTTON CANDY
    sodium fluoride gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-773
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDY (COTTON CANDY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-773-16480 mL in 1 BOTTLE; 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)
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