Kolorz Sixty Second Fluoride Foam

Generic Name: sodium fluoride

Dosage Form: dental aerosol, foam
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 NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 10733-357-00 6 CAN In 1 BOX contains a CAN 1 125 g In 1 CAN This package is contained within the BOX (10733-357-00)

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: 03/2011Medical Products Laboratories, Inc.

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• Prevention of Dental Caries