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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

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-772
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
Product Characteristics
Color Score
ShapeSize
FlavorCHERRY (CHERRY CHEESECAKE) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-772-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/22/2006
KOLORZ SIXTY SECOND FLUORIDE PINA COLADA
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-775
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
Product Characteristics
Color Score
ShapeSize
FlavorPINEAPPLE (PIÑA COLADA) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-775-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/22/2006
KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-771
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
Product Characteristics
Color Score
ShapeSize
FlavorMINT (TRIPLE MINT) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-771-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/22/2006
KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-774
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
Product Characteristics
Color Score
ShapeSize
FlavorRASPBERRY (BLUE RASPBERRY) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-774-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/22/2006
KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25047-773
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE12.3 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
Product Characteristics
Color Score
ShapeSize
FlavorCOTTON CANDY (COTTON CANDY) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25047-773-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER11/22/2006
Labeler - DMG AMERICA, LLC (106792427)

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