Label: KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT- sodium fluoride aerosol, foam
- NDC Code(s): 25047-765-44
- 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
If you are a consumer or patient please visit this version.
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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.
- CONTAINS
- WARNING
- EMERGENCY RESPONSE
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INSTRUCTIONS FOR USE
kolorz®
By DMG America
Instructions For UseKolorz 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.
Dosage and Administration:
- Shake can vigorously before each use. (Fig. 1)
- 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)
- Dry tooth surface and insert tray(s) in mouth.
- 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.
- Remove tray(s) and have patient expectorate excess
- 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.com395490 Rev. 11/13
- Shake can vigorously before each use. (Fig. 1)
- PRINCIPAL DISPLAY PANEL - 125 g Can Carton
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INGREDIENTS AND APPEARANCE
KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT
sodium fluoride aerosol, foamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25047-765 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.9 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color Score Shape Size Flavor MINT (TRIPLE MINT) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25047-765-44 125 g in 1 CAN; Type 0: Not a Combination Product 11/22/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 11/22/2006 Labeler - DMG AMERICA, LLC (106792427) Establishment Name Address ID/FEI Business Operations Medical Products Laboratories, Inc. 002290302 MANUFACTURE(25047-765) , PACK(25047-765) , LABEL(25047-765)
