COLGATE BAKUGAN FLUORIDE MILD BUBBLEFRUIT FLAVOR- sodium fluoride gel, 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 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, cellulose gum, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, sodium saccharin, mica, 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.colgate.com

PRINCIPAL DISPLAY PANEL - 130 g Carton

CLINICALLY
PROVEN
Cavity Protection

BAKUGAN
BATTLE BRAWLERS

Colgate®
Fluoride Toothpaste

Mild
Bubble
Fruit®
Flavor

ADA
Accepted
American
Dental
Association®

Toothpaste

NET WT
4.6 OZ
(130 g)

CN
CARTOON NETWORK™

Principal Display Panel - 130 g Carton
COLGATE  BAKUGAN FLUORIDE MILD BUBBLEFRUIT FLAVOR
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-537
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
water (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (Blue Pearlescent Gel) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51442-537-46130 g in 1 TUBE; Type 0: Not a Combination Product11/18/200906/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/18/200906/01/2019
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 9/2019
Document Id: 74a70610-6b0e-412a-86e6-de9c1ae64961
Set id: d2b3f40f-bf3e-414a-b7d2-577e73c7d2a9
Version: 2
Effective Time: 20190906
 
Colgate-Palmolive Canada