COLGATE TRIPLE ACTION ORIGINAL MINT FLUORIDE- sodium fluoride 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.

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Colgate®
Fluoride Toothpaste

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of the 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

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

Questions or comments?

Call 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 181 g Carton

Colgate®
Fluoride Toothpaste

NET WT 6.4 OZ (181 g)

Triple
Action
Original Mint

Cavity
Protection
1

Whiter
Teeth
2

Fresh
Breath
3

Principal Display Panel - 181 g Carton
COLGATE TRIPLE ACTION ORIGINAL MINT FLUORIDE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-536
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) Sodium Fluoride2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorBLUE, WHITE, GREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51442-536-641 in 1 CARTON04/07/201006/01/2019
1181 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/07/201006/01/2019
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 9/2019
Document Id: c1d024d8-ab53-4101-8958-eef3e64f49b4
Set id: 40a4e50a-da2a-41e3-bb6a-56e85c47a2f2
Version: 3
Effective Time: 20190911
 
Colgate-Palmolive Canada