FDA.reportPublic FDA data

KOLORZ NEUTRAL FLUORIDE FOAM

Manufacturer
DMG AMERICA, LLC | Medical Products Laboratories, Inc.
Effective date
2021-10-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:52:23

Label at a glance#

ProductKOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Label contents#

Full prescribing information#

INDICATIONS

INDICATIONS & USAGE SECTION

For the topical application of fluoride in a neutral base to aid in the protection against dental caries. Ideal for patients with extensive esthetic restorations and/or intolerance to acidic fluorides, Kolorz® Neutral Foam requires a 4-minute application.

Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.

FigureFigure

CONTAINS

DESCRIPTION SECTION

Sodium Fluoride in a proprietary neutral flavored foam base. 0.9% Fluoride Ion from 2% Sodium Fluoride at a neutral pH. This product does not contain chlorofluorocarbon propellant.

Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten free.

WARNING

WARNINGS SECTION

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.

EMERGENCY RESPONSE

SPL UNCLASSIFIED SECTION

Call Infotrac 1-800-535-5053

Made in USA

Distributed by: DMG America LLC.
242 South Dean Street
Englewood, NJ 07631
800-662-6383
www.dmg-america.com
Rev. 4/13

RE-ORDER #766205

INSTRUCTIONS FOR USE SECTION

kolorz®

By DMG America
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.

FigureFigure

Dosage and Administration:

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

    Fig. 1Fig. 1

  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)

    Fig. 2Fig. 2

  3. Dry tooth surface and insert tray(s) in mouth.
  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. Remove tray(s) and have patient expectorate excess
  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.

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

PRINCIPAL DISPLAY PANEL - 125 g Can Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Taste...
Guaranteed!

kolorz®

NEUTRAL
Fluoride Foam
Triple Mint

Neutral Sodium Fluoride
Contains 2.0% Sodium Fluoride
(0.9% Fluoride Ion)

GLUTEN FREE!

Contains
XYLITOL

CAUTION:
For professional use only.

Store at room temperature.

Shake well before each use.

NET WT. 4.4 OZ (125g)

PRINCIPAL DISPLAY PANEL - 125 g Can Carton
PRINCIPAL DISPLAY PANEL - 125 g Can Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
688397Kolorz 2 % Oral FoamPSN3
688393sodium fluoride 2 % Oral FoamPSN3
688397sodium fluoride 20 MG/ML Oral Foam [Kolorz]SBD3
688393sodium fluoride 20 MG/ML Oral FoamSCD3
688397Kolorz 2 % Oral FoamSY3
688397Kolorz 20 MG/ML Oral FoamSY3
688393sodium fluoride 2 % Oral FoamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25047-765-442021-10-04C16284748780-1ba0f9c33-2f61-a910-e053-dadaa90a0b85kolorz ® NEUTRAL Fluoride Foam
25047-765-442021-01-29C16284748780-1ba0f9c33-2f61-a910-e053-dadaa90a0b85kolorz ® NEUTRAL Fluoride Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25047-765-44KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT125 g in 1 CANAEROSOL, FOAM1253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25047-765KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT (SODIUM FLUORIDE) AEROSOL, FOAM [DMG AMERICA, LLC]3Current NDC, Legacy NDC, 1 package rows20230819_b83c62be-8e9d-4fa2-aa10-d34c88bf2387.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
25047-76525047-765-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLCb83c62be-8e9d-4fa2-aa10-d34c88bf23872021-10-01WarningsExact identifier
ndc (package): 25047-765-44
ndc (product): 25047-765
ndc11 (package): 25047076544
spl id: 79be0b6b-34c3-4e14-9702-54e7d4f1104e
spl set id: b83c62be-8e9d-4fa2-aa10-d34c88bf2387

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.