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| Product NDC Code | 25047-773 | ||||
|---|---|---|---|---|---|
| Drug Name | Kolorz sixty second fluoride cotton candy |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1535362, 2121950 |
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| Labeler Name | DMG AMERICA, LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS For topical application of fluoride to aid in the protection against dental caries.
Spl product data elements
Usually a list of ingredients in a drug product.KOLORZ SIXTY SECOND FLUORIDE CHERRY CHEESECAKE SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL COCAMIDOPROPYL BETAINE CHERRY CHEESECAKE KOLORZ SIXTY SECOND FLUORIDE PINA COLADA SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL COCAMIDOPROPYL BETAINE PIÑA COLADA KOLORZ SIXTY SECOND FLUORIDE TRIPLE MINT SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL COCAMIDOPROPYL BETAINE TRIPLE MINT KOLORZ SIXTY SECOND FLUORIDE BLUE RASPBERRY SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL COCAMIDOPROPYL BETAINE BLUE RASPBERRY KOLORZ SIXTY SECOND FLUORIDE COTTON CANDY SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL COCAMIDOPROPYL BETAINE COTTON CANDY
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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
Storage and handling
Information about safe storage and handling of the drug product.Store between 68-77° F. Keep from freezing.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNING Keep out of reach of children. Do not swallow. If dosage or less than 100mg is ingested, contact poison control.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API