COLGATE PROCLINICAL REFRESHING MINT- sodium monofluorophosphate paste, dentifrice 
Colgate-Palmolive Canada

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 monofluorophosphate 1.14% (0.20% 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, tetrapotassium pyrophosphate, PVM/MA copolymer, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, sucralose, titanium dioxide, mica, 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
RENEWAL
FOR ENAMEL

Formulated with ProMinerals™
complex. Fortifies enamel and
leaves gums feeling rejuvenated.

Refreshing Mint

NET WT 4.0 OZ (113 g)

Principal Display Panel - 113 g Carton
COLGATE PROCLINICAL REFRESHING MINT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-542
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE, GREEN (Stripe) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51442-542-691 in 1 CARTON12/08/200906/01/2019
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/08/200906/01/2019
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 9/2019
Document Id: ef3c1b95-68e1-4b37-bfa8-405b27f1acf2
Set id: 95e261e5-a8b4-462a-b484-4fcbf6e55648
Version: 3
Effective Time: 20190910
 
Colgate-Palmolive Canada