Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Clinpro 5000 Anti-Cavity Toothpaste is supplied as a white dentifrice paste in a 4 oz. (113 gm) plastic tube (NDC 48878-3120-4, Vanilla Mint Flavor; NDC 48878-3130-4 Spearmint Flavor; NDC 48878-3140-4 Bubble Gum Flavor). Storage This product is designed to be stored and used at room temperature. Do not freeze or expose to extreme heat. See outer package for expiration date. Manufactured for: 3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 USA Revision date: 01/11/2012 Rx Only 3M, ESPE, and Clinpro are trademarks of 3M or 3M Deutschland GmbH. © 3M 2016. All rights reserved.; Principal Display Panel – Box Label 3M ESPE NDC 48878-3120-4 Clinpro™ 5000 Vanilla Mint 1.1% Sodium Fluoride Anti-Cavity Toothpaste Innovative Tri-Calcium Phosphate Exclusively from 3M ESPE Contents: 1 Tube NET WT 4oz (113g) Rx Only Principal Display Panel – Box Label; Principal Display Panel – Box Label 3M ESPE NDC 48878-3130-4 Clinpro™ 5000 Spearmint 1.1% Sodium Fluoride Anti-Cavity Toothpaste Innovative Tri-Calcium Phosphate Exclusively from 3M ESPE Contents: 1 Tube NET WT 4oz (113g) Rx Only Principal Display Panel – Box Label; Principal Display Panel – Box Label 3M ESPE NDC 48878-3140-4 Clinpro™ 5000 Bubble Gum 1.1% Sodium Fluoride Anti-Cavity Toothpaste Innovative Tri-Calcium Phosphate Exclusively from 3M ESPE Contents: 1 Tube NET WT 4oz (113g) Rx Only Principal Display Panel – Box Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING Clinpro 5000 Anti-Cavity Toothpaste is supplied as a white dentifrice paste in a 4 oz. (113 gm) plastic tube (NDC 48878-3120-4, Vanilla Mint Flavor; NDC 48878-3130-4 Spearmint Flavor; NDC 48878-3140-4 Bubble Gum Flavor). Storage This product is designed to be stored and used at room temperature. Do not freeze or expose to extreme heat. See outer package for expiration date. Manufactured for: 3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 USA Revision date: 01/11/2012 Rx Only 3M, ESPE, and Clinpro are trademarks of 3M or 3M Deutschland GmbH. © 3M 2016. All rights reserved.
- Principal Display Panel – Box Label 3M ESPE NDC 48878-3120-4 Clinpro™ 5000 Vanilla Mint 1.1% Sodium Fluoride Anti-Cavity Toothpaste Innovative Tri-Calcium Phosphate Exclusively from 3M ESPE Contents: 1 Tube NET WT 4oz (113g) Rx Only Principal Display Panel – Box Label
- Principal Display Panel – Box Label 3M ESPE NDC 48878-3130-4 Clinpro™ 5000 Spearmint 1.1% Sodium Fluoride Anti-Cavity Toothpaste Innovative Tri-Calcium Phosphate Exclusively from 3M ESPE Contents: 1 Tube NET WT 4oz (113g) Rx Only Principal Display Panel – Box Label
- Principal Display Panel – Box Label 3M ESPE NDC 48878-3140-4 Clinpro™ 5000 Bubble Gum 1.1% Sodium Fluoride Anti-Cavity Toothpaste Innovative Tri-Calcium Phosphate Exclusively from 3M ESPE Contents: 1 Tube NET WT 4oz (113g) Rx Only Principal Display Panel – Box Label
Overview
Clinpro 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste is a self-applied fluoride dentifrice for the prevention of dental caries. Each gram contains 5 mg of fluoride ion in a neutral pH base, consisting of water, sorbitol, hydrated silica, glycerin, polyethylene-polypropylene glycol, flavor, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, carboxymethyl cellulose, sodium saccharin and tri-calcium phosphate.
Indications & Usage
Clinpro 5000 Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. Clinpro 5000 Anti-Cavity Toothpaste is indicated for use as part of a professional program for the prevention and control of dental caries. ( 1 )
Dosage & Administration
• Use once daily in place of conventional toothpaste unless instructed otherwise by a physician or dentist. • Apply a thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste using a soft-bristled toothbrush and brush teeth for at least two minutes. • After brushing adults should expectorate. Children 6 to 16 years of age should expectorate and rinse mouth thoroughly with water. • Follow these instructions or use as directed by a dental professional. Use once daily in place of conventional toothpaste unless instructed otherwise by a physician or dentist. ( 2 ) Apply a thin ribbon or pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste using a soft-bristled toothbrush and brush teeth for at least two minutes. ( 2 ) After brushing adults should expectorate. Children 6 to 16 years of age should expectorate and rinse mouth thoroughly with water. ( 2 )
Warnings & Precautions
• DO NOT SWALLOW. If more than a pea-sized amount of Clinpro 5000 Anti-Cavity Toothpaste is swallowed, contact a medical or dental professional or a poison control center. • Keep out of reach of children under 6 years of age. • Repeated ingestion of high levels of fluoride may cause dental fluorosis. For this reason, use in children with developing dentition requires special supervision to prevent swallowing. Prescribing dentists and physicians should consider risk of fluorosis when prescribing for use in children less than 6 years of age. Do not swallow. ( 5 ) Keep out of reach of children under 6 years of age. ( 5 ) Repeated ingestion of high levels of fluoride may cause dental fluorosis. ( 5 )
Contraindications
Do not use in children under 6 years of age unless recommended by a dentist or physician. Do not use in children under 6 years of age unless recommended by a dentist or physician. ( 4 )
Adverse Reactions
Allergic reactions and other idiosyncrasies have been rarely reported. Allergic reactions and other idiosyncrasies have been rarely reported. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact 3M ESPE Dental Products Division at 1-800-634-2249 or www.3MESPE.com , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Storage & Handling
Storage This product is designed to be stored and used at room temperature. Do not freeze or expose to extreme heat. See outer package for expiration date. Manufactured for: 3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144-1000 USA Revision date: 01/11/2012 Rx Only 3M, ESPE, and Clinpro are trademarks of 3M or 3M Deutschland GmbH. © 3M 2016. All rights reserved.
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