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| Product NDC Code | 25047-764 | ||||
|---|---|---|---|---|---|
| Drug Name | Kolorz sixty second fluoride foam blue raspberry |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| RxCUI drug identifier | 248389, 1093170 |
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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 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 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 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
Spl product data elements
Usually a list of ingredients in a drug product.KOLORZ SIXTY SECOND FLUORIDE FOAM BLUE RASPBERRY SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS COCAMIDOPROPYL BETAINE BLUE RASPBERRY KOLORZ SIXTY SECOND FLUORIDE FOAM CHERRY CHEESECAKE SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS COCAMIDOPROPYL BETAINE CHERRY CHEESECAKE KOLORZ SIXTY SECOND FLUORIDE FOAM COTTON CANDY SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS COCAMIDOPROPYL BETAINE KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINT SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SUCRALOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS COCAMIDOPROPYL BETAINE TRIPLE MINT
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 - 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 - Blue Raspberry
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 - Cherry Cheesecake
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 - Cotton Candy
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 - Triple Mint
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.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
Information about safe handling and use of the drug product.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 Figure Figure Figure
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 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.
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