KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [DMG AMERICA, LLC]

KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [DMG AMERICA, LLC]
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NDC 25047-765-44
Set ID b83c62be-8e9d-4fa2-aa10-d34c88bf2387
Category HUMAN PRESCRIPTION DRUG LABEL
Packager DMG AMERICA, LLC
Generic Name
Product Class
Product Number
Application Number
  • INDICATIONS

    For the topical application of fluoride in a neutral base to aid in the protection against dental caries. Ideal for patients with extensive esthetic restorations and/or intolerance to acidic fluorides, Kolorz® Neutral Foam requires a 4-minute application.

    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 neutral flavored foam base. 0.9% Fluoride Ion from 2% Sodium Fluoride at a neutral pH. This product 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 #766205

  • 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)

      Fig. 1

    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)

      Fig. 2

    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.

    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

    Best Taste...
    Guaranteed!

    kolorz®

    NEUTRAL
    Fluoride Foam
    Triple Mint

    Neutral Sodium Fluoride
    Contains 2.0% Sodium Fluoride
    (0.9% 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
  • INGREDIENTS AND APPEARANCE
    KOLORZ NEUTRAL FLUORIDE FOAM   TRIPLE MINT
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-765
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.9 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (TRIPLE MINT) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25047-765-44125 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)

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