FDA.reportPublic FDA data

kolorz ® Sixty Second Fluoride Gel

Manufacturer
DMG AMERICA, LLC | KEYSTONE INDUSTRIES
Effective date
2019-03-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:13:17

Label at a glance#

ProductKOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE
Active ingredientSODIUM FLUORIDE
Label structure13 sections

Storage and handling

Store between 68-77° F. Keep from freezing.

Label contents#

Full prescribing information#

INDICATIONS

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

CONTAINS

DESCRIPTION SECTION

Sodium Fluoride in a proprietary acidulated phosphate flavored gel base. 1.23% Fluoride Ion from 2.72% Sodium Fluoride.

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

WARNING

WARNINGS SECTION

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

STORAGE AND HANDLING SECTION

Store between 68-77° F. Keep from freezing.

SPL UNCLASSIFIED SECTION

Contains FD&C Blue #1.

EMERGENCY RESPONSE

SPL UNCLASSIFIED SECTION

Call Infotrac 1-800-535-5053

SPL UNCLASSIFIED SECTION

Made in USA

Distributed by :DMG America LLC, 242 South Dean Street
Englewood, NJ 07631, 800-662-6383
www.dmg-america.com
Rev. 4/09

RE-ORDER #777304
392415

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cherry Cheesecake

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Taste...
Guaranteed!

kolorz®

Sixty
Second
Fluoride Gel
Cherry Cheesecake

APF Topical Fluoride
Acidulated Phosphate Fluoride
1.23% Fluoride Ion

GLUTEN FREE!

Contains
XYLITOL

CAUTION:
For professional use only.

Shake well before each use.

NET WT. 16 OZ (480ml)

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cherry Cheesecake
PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cherry Cheesecake

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Piña Colada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Taste...
Guaranteed!

kolorz®

Sixty
Second
Fluoride Gel
Piña Colada

APF Topical Fluoride
Acidulated Phosphate Fluoride
1.23% Fluoride Ion

GLUTEN FREE!

Contains
XYLITOL

CAUTION:
For professional use only.

Shake well before each use.

NET WT. 16 OZ (480ml)

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Piña Colada
PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Piña Colada

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Triple Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Taste...
Guaranteed!

kolorz®

Sixty
Second
Fluoride Gel
Triple Mint

APF Topical Fluoride
Acidulated Phosphate Fluoride
1.23% Fluoride Ion

GLUTEN FREE!

Contains
XYLITOL

CAUTION:
For professional use only.

Shake well before each use.

NET WT. 16 OZ (480ml)

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Triple Mint
PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Triple Mint

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Blue Raspberry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Taste...
Guaranteed!

kolorz®

Sixty
Second
Fluoride Gel
Blue Raspberry

APF Topical Fluoride
Acidulated Phosphate Fluoride
1.23% Fluoride Ion

GLUTEN FREE!

Contains
XYLITOL

CAUTION:
For professional use only.

Shake well before each use.

NET WT. 16 OZ (480ml)

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Blue Raspberry
PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Blue Raspberry

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cotton Candy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Taste...
Guaranteed!

kolorz®

Sixty
Second
Fluoride Gel
Cotton Candy

APF Topical Fluoride
Acidulated Phosphate Fluoride
1.23% Fluoride Ion

GLUTEN FREE!

Contains
XYLITOL

CAUTION:
For professional use only.

Shake well before each use.

NET WT. 16 OZ (480ml)

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cotton Candy
PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cotton Candy

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2121950Kolorz Sixty Second Fluoride 2.72 % Oral GelPSN4
1535362sodium fluoride 2.72 % Oral GelPSN4
2121950sodium fluoride 0.0272 MG/MG Oral Gel [Kolorz]SBD4
1535362sodium fluoride 0.0272 MG/MG Oral GelSCD4
2121950Kolorz 0.0272 MG/MG Oral GelSY4
2121950Kolorz 2.72 % Oral GelSY4
1535362sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
25047-771-162021-09-30C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-772-162021-09-30C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-773-162021-09-30C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-774-162021-09-30C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-775-162021-09-30C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-771-162021-01-29C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-772-162021-01-29C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-773-162021-01-29C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-774-162021-01-29C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel
25047-775-162021-01-29C16284748780-1ba0f9c33-39b1-a910-e053-dadaa90a0b85kolorz ® Sixty Second Fluoride Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25047-771-16KOLORZ SIXTY SECOND FLUORIDETRIPLE MINT480 mL in 1 BOTTLEGEL4804
25047-772-16KOLORZ SIXTY SECOND FLUORIDECHERRY CHEESECAKE480 mL in 1 BOTTLEGEL4804
25047-773-16KOLORZ SIXTY SECOND FLUORIDECOTTON CANDY480 mL in 1 BOTTLEGEL4804
25047-774-16KOLORZ SIXTY SECOND FLUORIDEBLUE RASPBERRY480 mL in 1 BOTTLEGEL4804
25047-775-16KOLORZ SIXTY SECOND FLUORIDEPINA COLADA480 mL in 1 BOTTLEGEL4804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25047-771KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY (SODIUM FLUORIDE) GEL [DMG AMERICA, LLC]4Current NDC, Legacy NDC, 1 package rows20241003_21fa26f2-0162-4044-aec0-d5360be3f3e0.zip
25047-772KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY (SODIUM FLUORIDE) GEL [DMG AMERICA, LLC]4Current NDC, Legacy NDC, 1 package rows20241003_21fa26f2-0162-4044-aec0-d5360be3f3e0.zip
25047-773KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY (SODIUM FLUORIDE) GEL [DMG AMERICA, LLC]4Current NDC, Legacy NDC, 1 package rows20241003_21fa26f2-0162-4044-aec0-d5360be3f3e0.zip
25047-774KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY (SODIUM FLUORIDE) GEL [DMG AMERICA, LLC]4Current NDC, Legacy NDC, 1 package rows20241003_21fa26f2-0162-4044-aec0-d5360be3f3e0.zip
25047-775KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY (SODIUM FLUORIDE) GEL KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY (SODIUM FLUORIDE) GEL [DMG AMERICA, LLC]4Current NDC, Legacy NDC, 1 package rows20241003_21fa26f2-0162-4044-aec0-d5360be3f3e0.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
25047-77125047-771-16
25047-77225047-772-16
25047-77325047-773-16
25047-77425047-774-16
25047-77525047-775-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

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 SIXTY SECOND FLUORIDE TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLC21fa26f2-0162-4044-aec0-d5360be3f3e02019-03-28WarningsExact identifier
ndc (package): 25047-774-16
ndc (package): 25047-771-16
ndc (package): 25047-772-16
ndc (package): 25047-773-16
ndc (package): 25047-775-16
ndc (product): 25047-772
ndc (product): 25047-774
ndc (product): 25047-773
ndc (product): 25047-771
ndc (product): 25047-775
ndc11 (package): 25047077416
ndc11 (package): 25047077516
ndc11 (package): 25047077316
ndc11 (package): 25047077116
ndc11 (package): 25047077216
spl id: f15de5cf-4f64-472b-bda4-87daed17c864
spl set id: 21fa26f2-0162-4044-aec0-d5360be3f3e0

Reported adverse events (FAERS/openFDA)#

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