KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT- sodium fluoride aerosol, foam

KOLORZ NEUTRAL FLUORIDE FOAM by

Drug Labeling and Warnings

KOLORZ NEUTRAL FLUORIDE FOAM by is a Prescription medication manufactured, distributed, or labeled by DMG AMERICA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

1. Shake can vigorously before each use. (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)

   

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)

INGREDIENTS AND APPEARANCE

KOLORZ NEUTRAL FLUORIDE FOAM   TRIPLE MINT
sodium fluoride aerosol, foam

Product 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)