FDA Label for Kolorz Neutral Fluoride Foam Triple Mint
View Indications, Usage & Precautions
Kolorz Neutral Fluoride Foam Triple Mint Product Label
The following document was submitted to the FDA by the labeler of this product Dmg America, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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.
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.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)
* Please review the disclaimer below.