COLGATE  JUNIOR - PINK SPARKLE- 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.

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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 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, sodium lauryl sulfate, flavor, sodium saccharin, mica, titanium dioxide, FD&C red no. 40, D&C red no. 33

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

Colgate®
Fluoride Toothpaste

CLINICALLY PROVEN
Cavity & Enamel Protection

LPS

ADA
Accepted
American
Dental
Association ®

Littlest
PetShop™

Toothpaste

NET WT
4.6 OZ
(130 g)

MILD BUBBLE FRUIT® FLAVOR

Principal Display Panel - 130 g Tube Label
COLGATE   JUNIOR - PINK SPARKLE
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-545
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)  
water (UNII: 059QF0KO0R)  
hydrated silica (UNII: Y6O7T4G8P9)  
Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
sodium lauryl sulfate (UNII: 368GB5141J)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
mica (UNII: V8A1AW0880)  
D&C Red No. 33 (UNII: 9DBA0SBB0L)  
titanium dioxide (UNII: 15FIX9V2JP)  
FD&C red no. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorRED (RED Pearlescent Gel) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51442-545-46130.7 g in 1 TUBE; Type 0: Not a Combination Product07/25/201106/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/25/201106/01/2019
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 9/2019
Document Id: 0a9bf467-b4af-49f9-ac41-757822c35ccb
Set id: 3cc23a5e-1c63-48f5-a16f-e4403bccad41
Version: 3
Effective Time: 20190909
 
Colgate-Palmolive Canada