Label: KOLORZ - sodium fluoride aerosol, foam
- NDC Code(s): 10733-395-00
- Packager: Medical Products Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated March 11, 2011
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- 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.
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.
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 & USAGE
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
- INGREDIENTS AND APPEARANCE
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