Indications
For topical application of fluoride to aid in the protection against dental caries.
Kolorz Sixty Second Fluoride Gel
FDA Label NDC 25047-772
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 (NDC 25047-772). 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, dosage & administration, contains, warning, storage and handling, other, emergency response, principal display panel - 480 ml bottle label - cherry cheesecake, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Storage And Handling
Store between 68-77° F. Keep from freezing.
Other
Contains FD&C Blue #1.
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
Emergency Response
Call Infotrac 1-800-535-5053
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)
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)
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)
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)
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)
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