COLGATE  GREAT REGULAR FLAVOR- 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.

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Colgate®
Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (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

dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call toll-free 1-800-468-6502

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

www.colgate.com

PRINCIPAL DISPLAY PANEL - 85 gram Tube

Colgate®
Fluoride Toothpaste

ADA
Accepted
American
Dental
Association®

NET WT 3.0 OZ (85 g)

Cavity
Protection

Strengthens Teeth
with Active Fluoride

Great Regular Flavor

PRINCIPAL DISPLAY PANEL - 85 gram Tube

PRINCIPAL DISPLAY PANEL - 85 gram Tube Carton

Colgate®
Fluoride Toothpaste

ADA
Accepted
American
Dental
Association®

NET WT 3.0 OZ (85 g)

Cavity
Protection

Strengthens Teeth
with Active Fluoride

Great Regular Flavor

PRINCIPAL DISPLAY PANEL - 85 gram Tube Carton
COLGATE   GREAT REGULAR FLAVOR
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-330
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) fluoride ion7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51442-330-631 in 1 CARTON06/04/200906/01/2019
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/04/200906/01/2019
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 9/2019
Document Id: e7835997-22b5-4fe5-bda2-40a11532b350
Set id: ce5c6085-718d-409b-8d0f-e2e8419016c4
Version: 2
Effective Time: 20190910
 
Colgate-Palmolive Canada