Kolorz Fluoride Foam
Package insert / prescribing information
Generic name: sodium fluoride
Dosage form: aerosol, foam
Drug class: Mouth and throat products
Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.
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.
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.
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.
Call Infotrac 1-800-535-5053
Made in USA
Distributed by: DMG America LLC.
242 South Dean Street
Englewood, NJ 07631
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.
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
395490 Rev. 11/13
PRINCIPAL DISPLAY PANEL - 125 g Can Carton
Neutral Sodium Fluoride
Contains 2.0% Sodium Fluoride
(0.9% Fluoride Ion)
For professional use only.
Store at room temperature.
Shake well before each use.
NET WT. 4.4 OZ (125g)
|KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT
sodium fluoride aerosol, foam
|Labeler - DMG AMERICA, LLC (106792427)|
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