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Kolorz (Sodium fluoride): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
1.23 mg/g, 1.23 g/g
Other brand names:
Active ingredient:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Kolorz

Instructions For Use

Kolorz Sixty Second Fluoride Foam

Kolorz Neutral Fluoride Foam

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.

Dosage and Administration:

  1. 1.

    Shake can vigorously before each use. (Fig. 1)

  2. 2.

    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. (Fig. 2)

  3. 3. Dry tooth surface and insert tray(s) in mouth.
  4. 4. For Kolorz Sixty Second Fluoride Foam: Have patient bite down lightly but firmly for 1 to 4 minutes; For Kolorz Neutral Fluoride Foam: Have patient bite down lightly but firmly for 4 minutes.
  5. 5. Remove tray(s) and have patient expectorate excess
  6. 6. Instruct patient not to eat, drink, or rinse for at least 30 minutes after application.

How Supplied: Both Kolorz Sixty Second Fluoride Foam and Kolorz Neutral Fluoride Foam are available in 4.4oz. (125g) cans and do not contain chlorofluorocarbon propellant.

Caution: For professional use only. Federal U.S.A. Law prohibits dispensing without prescription.

Warning: Contents under pressure. Do not puncture or incinerate. Store between 55-80° F. Keep from freezing.

kolorz®

Distributed by DMG America

242 South Dean Street

Englewood, NJ 07631 USA

Tel: 201-894-5505

Fax: 201-894-0213

www.dmg-america.com

395490 Rev. 11/13

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: November 2013

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Kolorz

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Sodium fluoride 1.23 mg/g
Dosage form Aerosol, foam
Route Dental
Marketing status listed in the FDA NDC Directory
Company (applicant) DMG AMERICA, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 2 labelers list this drug on DailyMed
Packages (NDC)
Package
1.23 mg/g – 125 g in 1 can NDC 25047-764-44
1.23 g/g – 125 g in 1 can NDC 25047-762-44
1.23 g/g – 125 g in 1 can NDC 25047-763-44
1.23 g/g – 125 g in 1 can NDC 25047-761-44

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.