KOLORZ- sodium fluoride aerosol, foam

kolorz by

Drug Labeling and Warnings

kolorz by is a Prescription medication manufactured, distributed, or labeled by Medical Products Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Dosage and Administration
Shake can vigorously before each use. 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. Dry tooth surface and insert tray(s) in mouth. Have patient bite down lightly but firmly for 1 to 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.

Instructions For Use
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.

CONTAINS
Sodium Fluoride in a proprietary acidulated phosphate flavored foam base. 1.23% Fluoride Ion is available from 2.72% Sodium Fluoride. Does not contain chlorofluorocarbon propellant. Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten free.

WARNINGS

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.

PRECAUTIONS

CAUTION
For professional use only. Federal U.S.A. Law prohibits dispensing without prescription. Shake well before each use.

HOW SUPPLIED

How Supplied
Kolorz Sixty Second Fluoride Foam is available in 4.4 oz. (125g) can and do not contain chlorofluorocarbon propellant.

INDICATIONS & USAGE

INDICATIONS
For the topical application of fluoride to aid in the protection against dental caries. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.

PRINCIPAL DISPLAY PANEL

kolorz

INGREDIENTS AND APPEARANCE

KOLORZ 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 10733-395
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	27.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
BETAINE (UNII: 3SCV180C9W)
POLOXAMER 407 (UNII: TUF2IVW3M2)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Flavor) , CHEESE (Cheesecake Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10733-395-00	6 in 1 BOX
1		125 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2007

Labeler - Medical Products Laboratories, Inc. (002290302)

Registrant - Medical Products Laboratories, Inc. (002290302)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc.		002290302	analysis, manufacture, label, pack