Colgate Junior - Pink Sparkle

Dosage form: gel, dentifrice
Ingredients: Sodium Fluoride 2.4mg in 1g
Labeler: Colgate-Palmolive Canada
NDC Code: 51442-545

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 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

COLGATE   JUNIOR - PINK SPARKLE
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-545
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (FLUORIDE ION) Sodium Fluoride2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
sorbitol 
water 
hydrated silica 
Polyethylene Glycol 600 
Carboxymethylcellulose Sodium 
sodium lauryl sulfate 
Saccharin Sodium 
mica 
D&C Red No. 33 
titanium dioxide 
FD&C red no. 40 
Product Characteristics
ColorRED (RED Pearlescent Gel) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51442-545-46130.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/25/2011
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 11/2011
 
Colgate-Palmolive Canada

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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