Kolorz Sixty Second Fluoride Foam

Generic Name: sodium fluoride
Dosage Form: dental aerosol, foam

Disclaimer: 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.

Kolorz Sixty Second Fluoride Foam Triple Mint

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.

Kolorz Sixty Second Fluoride Foam Triple Mint

KOLORZ 
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:10733-357
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 27.2 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
SUCRALOSE  
XYLITOL  
SODIUM PHOSPHATE, MONOBASIC  
BETAINE  
POLOXAMER 407  
Product Characteristics
Color      Score     
Shape Size
Flavor PEPPERMINT (Peppermint Oil) , SPEARMINT (Spearmint Oil) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:10733-357-00 6 CAN (CAN) 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 Operations
Medical Products Laboratories, Inc. 002290302 analysis, manufacture, label, pack
Revised: 03/2011
 
Medical Products Laboratories, Inc.



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