FDA Label for Kolorz
View Indications, Usage & Precautions
Kolorz Product Label
The following document was submitted to the FDA by the labeler of this product Medical Products Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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.
Warnings
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.
Precautions
CAUTIONFor professional use only. Federal U.S.A. Law prohibits dispensing without prescription. Shake well before each use.
How Supplied
How Supplied
Kolorz Sixty Second Fluoride Foam is available in 4.4 oz. (125g) can and do not contain chlorofluorocarbon propellant.
Indications & Usage
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.
Package Label.Principal Display Panel
kolorz
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