Kolorz Sixty Second Fluoride Gel: Package Insert / Prescribing Info

Package insert / product label
Generic name: sodium fluoride
Dosage form: gel
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Sep 26, 2024.

Indications and Usage for Kolorz Sixty Second Fluoride Gel

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

Kolorz Sixty Second Fluoride Gel Dosage and 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.

Kolorz Sixty Second Fluoride Gel Description

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.

Warnings

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

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

Contains FD&C Blue #1.

EMERGENCY RESPONSE

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. 4/09

RE-ORDER #777304
392415

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PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cherry Cheesecake

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 - Piña Colada

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 - Triple Mint

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 - Blue Raspberry

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 - Cotton Candy

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

KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:25047-772
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	12.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (CHERRY CHEESECAKE)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:25047-772-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		11/22/2006

KOLORZ SIXTY SECOND FLUORIDE PINA COLADA
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:25047-775
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	12.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Product Characteristics
Color		Score
Shape		Size
Flavor	PINEAPPLE (PIÑA COLADA)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:25047-775-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		11/22/2006

KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:25047-771
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	12.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (TRIPLE MINT)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:25047-771-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		11/22/2006

KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:25047-774
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	12.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY (BLUE RASPBERRY)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:25047-774-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		11/22/2006

KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:25047-773
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	12.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY (COTTON CANDY)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:25047-773-16	480 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/22/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED DRUG OTHER		11/22/2006

Labeler - DMG AMERICA, LLC (106792427)

Kolorz Sixty Second Fluoride Gel: Package Insert / Prescribing Info

On This Page

Indications and Usage for Kolorz Sixty Second Fluoride Gel

Kolorz Sixty Second Fluoride Gel Dosage and Administration

Kolorz Sixty Second Fluoride Gel Description

Warnings

EMERGENCY RESPONSE

Related/similar drugs

Prevident

Biotene

Botox

Dentagel

Denta 5000 Plus

ACT Fluoride Rinse

Control Rx

Fluoride

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cherry Cheesecake

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Piña Colada

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Triple Mint

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Blue Raspberry

PRINCIPAL DISPLAY PANEL - 480 ml Bottle Label - Cotton Candy

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