Your browser does not support JavaScript! KOLORZ (SODIUM FLUORIDE) AEROSOL, FOAM [MEDICAL PRODUCTS LABORATORIES, INC.]
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KOLORZ (sodium fluoride) aerosol, foam
[Medical Products Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

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.

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.


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

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

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.

image of package insert

kolorz

image of can label

KOLORZ 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:10733-395
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE27.2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SUCRALOSE 
XYLITOL 
SODIUM PHOSPHATE, MONOBASIC 
BETAINE 
POLOXAMER 407 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) , CHEESE (Cheesecake Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10733-395-006 in 1 BOX
1125 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2007
Labeler - Medical Products Laboratories, Inc. (002290302)
Registrant - Medical Products Laboratories, Inc. (002290302)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories, Inc.002290302analysis, manufacture, label, pack

Revised: 3/2011
 
Medical Products Laboratories, Inc.

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