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Kolorz Sixty Second Fluoride Gel

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

Medically reviewed by Drugs.com. Last updated on Feb 21, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

INDICATIONS

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

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.

CONTAINS

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

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

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 - 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 - 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 - 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 - 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)

KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:25047-772
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 12.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SUCRALOSE
XYLITOL
COCAMIDOPROPYL BETAINE
Product Characteristics
Color Score
Shape Size
Flavor CHERRY (CHERRY CHEESECAKE) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:25047-772-16 480 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/22/2006
KOLORZ SIXTY SECOND FLUORIDE PINA COLADA
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:25047-775
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 12.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SUCRALOSE
XYLITOL
COCAMIDOPROPYL BETAINE
Product Characteristics
Color Score
Shape Size
Flavor PINEAPPLE (PIÑA COLADA) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:25047-775-16 480 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/22/2006
KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:25047-771
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 12.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SUCRALOSE
XYLITOL
COCAMIDOPROPYL BETAINE
Product Characteristics
Color Score
Shape Size
Flavor MINT (TRIPLE MINT) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:25047-771-16 480 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/22/2006
KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:25047-774
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 12.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SUCRALOSE
XYLITOL
COCAMIDOPROPYL BETAINE
Product Characteristics
Color Score
Shape Size
Flavor RASPBERRY (BLUE RASPBERRY) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:25047-774-16 480 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/22/2006
KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:25047-773
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 12.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SUCRALOSE
XYLITOL
COCAMIDOPROPYL BETAINE
Product Characteristics
Color Score
Shape Size
Flavor COTTON CANDY (COTTON CANDY) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:25047-773-16 480 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/22/2006
Labeler - DMG AMERICA, LLC (106792427)
DMG AMERICA, LLC

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