Kolorz Fluoride Foam
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.
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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
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
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.
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 Neutra