Drugplain

KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY 12.3 mg/mL

SODIUM FLUORIDE · GEL · DMG AMERICA, LLC

No Recall HistoryCurrently in Shortage
Plain English

KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY is a gel containing sodium fluoride at 12.3 mg/mL, taken dental. Manufactured by DMG AMERICA, LLC.

Key Facts

Brand Name
KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY
Generic Name
SODIUM FLUORIDE
NDC Code (Product)
25047-774
Manufacturer
DMG AMERICA, LLC
Strength
12.3 mg/mL
Dosage Form
GEL
Route
DENTAL
Marketing Status
Marketing Start
11/22/2006

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS For topical application of fluoride to aid in the protection against dental caries.

Dosage & Administration

DOSAGE & ADMINISTRATION Fill fluoride tray(s) 1/3 full with gel. Dry tooth surface and insert tray(s) in mouth. Have patient bite down for 60 seconds (or up to 4 minutes). Slight chewing motion provides interproximal coverage. Remove tray(s) and have patient expectorate excess gel. Advise patient not to eat, drink or rinse for 30 minutes.

Warnings

WARNING Keep out of reach of children. Do not swallow. If dosage or less than 100mg is ingested, contact poison control.

Frequently Asked Questions

What is KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY used for?

KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY contains SODIUM FLUORIDE. It is a gel taken dental. Consult your doctor for specific uses.

Is KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY a controlled substance?

KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY is not classified as a controlled substance by the DEA.

What is the generic name for KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY?

The generic name for KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY is SODIUM FLUORIDE. There are 12 other brand versions of SODIUM FLUORIDE.

What is the NDC code for KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY 12.3 mg/mL?

The NDC (National Drug Code) for KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY 12.3 mg/mL is 25047-774, listed by DMG AMERICA, LLC.