Kolorz®

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (12.3 mg)

Inactive Ingredients

Water Sucralose Xylitol Cocamidopropyl Betaine

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2006-11-22

Medication Information

Description

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

Section 42229-5

Contains FD&C Blue #1.

Section 44425-7

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

Warning

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

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.

Indications

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

Emergency Response

Call Infotrac 1-800-535-5053

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.

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 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 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 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 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)

Structured Label Content

Section 42229-5 (42229-5)

Contains FD&C Blue #1.

Section 44425-7 (44425-7)

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

Warning (WARNING)

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

Contains (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.

Indications (INDICATIONS)

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

Emergency Response (EMERGENCY RESPONSE)

Call Infotrac 1-800-535-5053

Dosage & Administration (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.

Principal Display Panel 480 Ml Bottle Label Triple Mint (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 Cotton Candy (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 Piña Colada (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 Blue Raspberry (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 Cherry Cheesecake (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)

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "12.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "12.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "12.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "12.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "12.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"42229-5": "Contains FD&C Blue #1.", "44425-7": "Store between 68-77° F. Keep from freezing.", "WARNING": "Keep out of reach of children. Do not swallow. If dosage or less than 100mg is ingested, contact poison control.", "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.", "INDICATIONS": "For topical application of fluoride to aid in the protection against dental caries.", "EMERGENCY RESPONSE": "Call Infotrac 1-800-535-5053", "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.", "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 - 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 - 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 - 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 - 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)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information