Colgate Proclinical - Clean Mint

Dosage form: paste, dentifrice
Ingredients: Sodium Fluoride 2.4mg in 1g
Labeler: Colgate-Palmolive Canada
NDC Code: 51442-544

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, cocamidopropyl betaine, sodium hydroxide, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

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®
FLUORIDE TOOTHPASTE

PRO
CLINICAL™
PROFESSIONALLY INSPIRED.
CLINICALLY PROVEN TECHNOLOGY.™

DAILY
CLEANING

Polishes with Prophy Silica™,
an ingredient similar to what
dentists use. Removes plaque
and fights stains.

Clean Mint

NET WT 4.0 OZ (113 g)

COLGATE PROCLINICAL - CLEAN MINT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-544
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (FLUORIDE ION) Sodium Fluoride2.4 mg  in 1 g
Product Characteristics
ColorWHITE (Green Speckles) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51442-544-691 TUBE (TUBE) in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/25/2010
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 01/2010
 
Colgate-Palmolive Canada

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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