Kolorz Sixty Second Fluoride Foam Aerosol, Foam
FDA Label NDC 25047-762

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dmg America, Llc for the product Kolorz Sixty Second Fluoride Foam (NDC 25047-762). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding indications, contains, warning, emergency response, instructions for use, principal display panel - 125 g can carton - blue raspberry, principal display panel - 125 g can carton - cherry cheesecake, principal display panel - 125 g can carton - cotton candy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Figure (Kolorz 01)

Figure (Kolorz 01)

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.

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.

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

Instructions For Use

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.

Figure (Kolorz 02)

Figure (Kolorz 02)

Dosage and Administration:

  • Shake can vigorously before each use. (Fig. 1)

    Figure (Kolorz 03)

    Figure (Kolorz 03)

  • 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)

    Figure (Kolorz 04)

    Figure (Kolorz 04)

  • 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

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)

Principal Display Panel (125 g Can Carton)

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)

Principal Display Panel (125 g Can Carton)

Principal Display Panel (125 g Can Carton)

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)

Principal Display Panel (125 g Can Carton)

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)

Principal Display Panel (125 g Can Carton)

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