Kolorz®

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.23 mg)

Inactive Ingredients

Water Sucralose Xylitol Sodium Phosphate, Monobasic, Anhydrous Cocamidopropyl Betaine

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2006-11-22

Medication Information

Description

For the topical application of fluoride to aid in the protection against dental caries. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.

Section 59845-8

kolorz^®

By DMG America

Instructions For Use

Kolorz Sixty Second Fluoride Foam

Kolorz Neutral Fluoride Foam

The first time you dispense from a new bottle, gently lift upward on the nozzle to break the protective shipping tab (thin plastic tab located adjacent to "trigger"). If this tab is not broken, there could be an initial surge of foam from the dispenser.

Dosage and Administration:

Shake can vigorously before each use. (Fig. 1)
Turn can completely upside down to dispense. Point can towards fluoride applicator tray and slowly press the nozzle to fill tray. Use one press per arch, as foam will expand slightly to fill the tray. (Fig. 2)
Dry tooth surface and insert tray(s) in mouth.
For Kolorz Sixty Second Fluoride Foam: Have patient bite down lightly but firmly for 1 to 4 minutes; For Kolorz Neutral Fluoride Foam: Have patient bite down lightly but firmly for 4 minutes.
Remove tray(s) and have patient expectorate excess
Instruct patient not to eat, drink, or rinse for at least 30 minutes after application.

How Supplied: Both Kolorz Sixty Second Fluoride Foam and Kolorz Neutral Fluoride Foam are available in 4.4oz. (125g) cans and do not contain chlorofluorocarbon propellant.

Caution: For professional use only. Federal U.S.A. Law prohibits dispensing without prescription.

Warning: Contents under pressure. Do not puncture or incinerate. Store between 55-80° F. Keep from freezing.

kolorz^®

Distributed by DMG America

242 South Dean Street

Englewood, NJ 07631 USA

Tel: 201-894-5505

Fax: 201-894-0213

www.dmg-america.com

395490 Rev. 11/13

Warning

Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 55-80° F. Keep from freezing.

Contains

Sodium Fluoride in a proprietary acidulated phosphate flavored foam base. 1.23% Fluoride Ion is available from 2.72% Sodium Fluoride. Does not contain chlorofluorocarbon propellant.

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

Indications

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

Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.

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. 4/13

RE-ORDER #766202

Principal Display Panel 125 G Can Carton Triple Mint

Best Taste…

Guaranteed!

kolorz^®

Sixty

Second

Fluoride Foam

Triple Mint

APF Topical Fluoride

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

GLUTEN FREE!

Contains

XYLITOL

CAUTION:

For professional use only.

Store at room temperature.

Shake well before each use.

NET WT. 4.4 OZ (125g)

Principal Display Panel 125 G Can Carton Cotton Candy

Best Taste…

Guaranteed!

kolorz^®

Sixty

Second

Fluoride Foam

Cotton Candy

APF Topical Fluoride

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

GLUTEN FREE!

Contains

XYLITOL

CAUTION:

For professional use only.

Store at room temperature.

Shake well before each use.

NET WT. 4.4 OZ (125g)

Principal Display Panel 125 G Can Carton Blue Raspberry

Best Taste…

Guaranteed!

kolorz^®

Sixty

Second

Fluoride Foam

Blue Raspberry

APF Topical Fluoride

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

GLUTEN FREE!

Contains

XYLITOL

CAUTION:

For professional use only.

Store at room temperature.

Shake well before each use.

NET WT. 4.4 OZ (125g)

Principal Display Panel 125 G Can Carton Cherry Cheesecake

Best Taste…

Guaranteed!

kolorz^®

Sixty

Second

Fluoride Foam

Cherry Cheesecake

APF Topical Fluoride

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

GLUTEN FREE!

Contains

XYLITOL

CAUTION:

For professional use only.

Store at room temperature.

Shake well before each use.

NET WT. 4.4 OZ (125g)

Structured Label Content

Section 59845-8 (59845-8)

kolorz^®

By DMG America

Instructions For Use

Kolorz Sixty Second Fluoride Foam

Kolorz Neutral Fluoride Foam

The first time you dispense from a new bottle, gently lift upward on the nozzle to break the protective shipping tab (thin plastic tab located adjacent to "trigger"). If this tab is not broken, there could be an initial surge of foam from the dispenser.

Dosage and Administration:

Shake can vigorously before each use. (Fig. 1)
Turn can completely upside down to dispense. Point can towards fluoride applicator tray and slowly press the nozzle to fill tray. Use one press per arch, as foam will expand slightly to fill the tray. (Fig. 2)
Dry tooth surface and insert tray(s) in mouth.
For Kolorz Sixty Second Fluoride Foam: Have patient bite down lightly but firmly for 1 to 4 minutes; For Kolorz Neutral Fluoride Foam: Have patient bite down lightly but firmly for 4 minutes.
Remove tray(s) and have patient expectorate excess
Instruct patient not to eat, drink, or rinse for at least 30 minutes after application.

How Supplied: Both Kolorz Sixty Second Fluoride Foam and Kolorz Neutral Fluoride Foam are available in 4.4oz. (125g) cans and do not contain chlorofluorocarbon propellant.

Caution: For professional use only. Federal U.S.A. Law prohibits dispensing without prescription.

Warning: Contents under pressure. Do not puncture or incinerate. Store between 55-80° F. Keep from freezing.

kolorz^®

Distributed by DMG America

242 South Dean Street

Englewood, NJ 07631 USA

Tel: 201-894-5505

Fax: 201-894-0213

www.dmg-america.com

395490 Rev. 11/13

Warning (WARNING)

Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 55-80° F. Keep from freezing.

Contains (CONTAINS)

Sodium Fluoride in a proprietary acidulated phosphate flavored foam base. 1.23% Fluoride Ion is available from 2.72% Sodium Fluoride. Does not contain chlorofluorocarbon propellant.

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

Indications (INDICATIONS)

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

Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.

Emergency Response (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. 4/13

RE-ORDER #766202

Principal Display Panel 125 G Can Carton Triple Mint (PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Triple Mint)

Best Taste…

Guaranteed!

kolorz^®

Sixty

Second

Fluoride Foam

Triple Mint

APF Topical Fluoride

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

GLUTEN FREE!

Contains

XYLITOL

CAUTION:

For professional use only.

Store at room temperature.

Shake well before each use.

NET WT. 4.4 OZ (125g)

Principal Display Panel 125 G Can Carton Cotton Candy (PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cotton Candy)

Best Taste…

Guaranteed!

kolorz^®

Sixty

Second

Fluoride Foam

Cotton Candy

APF Topical Fluoride

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

GLUTEN FREE!

Contains

XYLITOL

CAUTION:

For professional use only.

Store at room temperature.

Shake well before each use.

NET WT. 4.4 OZ (125g)

Principal Display Panel 125 G Can Carton Blue Raspberry (PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Blue Raspberry)

Best Taste…

Guaranteed!

kolorz^®

Sixty

Second

Fluoride Foam

Blue Raspberry

APF Topical Fluoride

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

GLUTEN FREE!

Contains

XYLITOL

CAUTION:

For professional use only.

Store at room temperature.

Shake well before each use.

NET WT. 4.4 OZ (125g)

Principal Display Panel 125 G Can Carton Cherry Cheesecake (PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cherry Cheesecake)

Best Taste…

Guaranteed!

kolorz^®

Sixty

Second

Fluoride Foam

Cherry Cheesecake

APF Topical Fluoride

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

GLUTEN FREE!

Contains

XYLITOL

CAUTION:

For professional use only.

Store at room temperature.

Shake well before each use.

NET WT. 4.4 OZ (125g)

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "1.23", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"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": "SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS", "unii": "KH7I04HPUU", "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": "1.23", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"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": "SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS", "unii": "KH7I04HPUU", "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": "1.23", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"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": "SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS", "unii": "KH7I04HPUU", "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": "1.23", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"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": "SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS", "unii": "KH7I04HPUU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"59845-8": "kolorz ® By DMG America Instructions For Use Kolorz Sixty Second Fluoride Foam Kolorz Neutral Fluoride Foam The first time you dispense from a new bottle, gently lift upward on the nozzle to break the protective shipping tab (thin plastic tab located adjacent to "trigger"). If this tab is not broken, there could be an initial surge of foam from the dispenser. Dosage and Administration: Shake can vigorously before each use. (Fig. 1) Turn can completely upside down to dispense. Point can towards fluoride applicator tray and slowly press the nozzle to fill tray. Use one press per arch, as foam will expand slightly to fill the tray. (Fig. 2) Dry tooth surface and insert tray(s) in mouth. For Kolorz Sixty Second Fluoride Foam: Have patient bite down lightly but firmly for 1 to 4 minutes; For Kolorz Neutral Fluoride Foam: Have patient bite down lightly but firmly for 4 minutes. Remove tray(s) and have patient expectorate excess Instruct patient not to eat, drink, or rinse for at least 30 minutes after application. How Supplied: Both Kolorz Sixty Second Fluoride Foam and Kolorz Neutral Fluoride Foam are available in 4.4oz. (125g) cans and do not contain chlorofluorocarbon propellant. Caution: For professional use only. Federal U.S.A. Law prohibits dispensing without prescription. Warning: Contents under pressure. Do not puncture or incinerate. Store between 55-80° F. Keep from freezing. kolorz ® Distributed by DMG America 242 South Dean Street Englewood, NJ 07631 USA Tel: 201-894-5505 Fax: 201-894-0213 www.dmg-america.com 395490 Rev. 11/13", "WARNING": "Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 55-80° F. Keep from freezing.", "CONTAINS": "Sodium Fluoride in a proprietary acidulated phosphate flavored foam base. 1.23% Fluoride Ion is available from 2.72% Sodium Fluoride. Does not contain chlorofluorocarbon propellant. Sweetened with Sucralose. Does not contain Aspartame or Saccharin. Gluten free.", "INDICATIONS": "For the topical application of fluoride to aid in the protection against dental caries. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.", "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. 4/13 RE-ORDER #766202", "PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Triple Mint": "Best Taste… Guaranteed! kolorz ® Sixty Second Fluoride Foam Triple Mint APF Topical Fluoride Acidulated Phosphate Fluoride 1.23% Fluoride Ion GLUTEN FREE! Contains XYLITOL CAUTION: For professional use only. Store at room temperature. Shake well before each use. NET WT. 4.4 OZ (125g)", "PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cotton Candy": "Best Taste… Guaranteed! kolorz ® Sixty Second Fluoride Foam Cotton Candy APF Topical Fluoride Acidulated Phosphate Fluoride 1.23% Fluoride Ion GLUTEN FREE! Contains XYLITOL CAUTION: For professional use only. Store at room temperature. Shake well before each use. NET WT. 4.4 OZ (125g)", "PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Blue Raspberry": "Best Taste… Guaranteed! kolorz ® Sixty Second Fluoride Foam Blue Raspberry APF Topical Fluoride Acidulated Phosphate Fluoride 1.23% Fluoride Ion GLUTEN FREE! Contains XYLITOL CAUTION: For professional use only. Store at room temperature. Shake well before each use. NET WT. 4.4 OZ (125g)", "PRINCIPAL DISPLAY PANEL - 125 g Can Carton - Cherry Cheesecake": "Best Taste… Guaranteed! kolorz ® Sixty Second Fluoride Foam Cherry Cheesecake APF Topical Fluoride Acidulated Phosphate Fluoride 1.23% Fluoride Ion GLUTEN FREE! Contains XYLITOL CAUTION: For professional use only. Store at room temperature. Shake well before each use. NET WT. 4.4 OZ (125g)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information