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COLGATE PROCLINICAL - Sparkling Mint

Medically reviewed on December 18, 2017

Dosage form: paste, dentifrice
Ingredients: Sodium Fluoride 2.4mg in 1g
Labeler: Colgate-Palmolive Canada
NDC Code: 51442-543

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Colgate®
FLUORIDE TOOTHPASTE

Drug Facts

Active ingredients

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

water, hydrated silica, sorbitol, glycerin, PEG-12, pentasodium triphosphate, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, polyethylene, cocoamidopropyl betaine, sodium hydroxide, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1

Questions or comments?

Call toll free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
Made in Canada
www.colgateproclinical.com

PRINCIPAL DISPLAY PANEL - 113 g Carton

Colgate®
Anticavity Fluoride Whitening Toothpaste

Paste

PRO
CLINICAL™
white

WHITER TEETH IN JUST 1 TUBE

NET WT 4.0 OZ (113 g)

Clinically Proven WHITENING TECHNOLOGY.

COLGATE PROCLINICAL - SPARKLING MINT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-543
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (FLUORIDE ION) Sodium Fluoride2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Hydrated Silica 
Sorbitol 
Glycerin 
Polyethylene Glycol 600 
Sodium Tripolyphosphate 
Sodium Pyrophosphate 
Sodium Lauryl Sulfate 
Carboxymethylcellulose Sodium 
Cocamidopropyl Betaine 
Sodium Hydroxide 
Saccharin Sodium 
Xanthan Gum 
Titanium Dioxide 
FD&C Blue No. 1 
Product Characteristics
ColorWHITE (Blue Speckles) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51442-543-691 TUBE (TUBE) in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/10/2010
Labeler - Colgate-Palmolive Canada (259157246)

 
Colgate-Palmolive Canada

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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