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kolorz

Medical Products Laboratories, Inc.
Medical Products Laboratories, Inc.

kolorz Sixty Second Fluoride Foam Triple Mint




FULL PRESCRIBING INFORMATION

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

CAUTION

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

Uses

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

kolorz Sixty Second Fluoride Foam Triple Mint

kolorz

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 27.2 mg

Inactive Ingredients

Ingredient Name Strength
water
Sucralose
Xylitol
sodium phosphate, monobasic
BETAINE
POLOXAMER 407

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 125 in 1 CAN
2 NDC:10733-357-00 6 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2007-01-01


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