COLGATE  JUNIOR DORA- sodium fluoride paste, dentifrice 
Mission Hills, S.A. de C.V.

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

Questions?

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

ADA
Accepted
American
Dental
Association ®

Toothpaste

nickelodeon™
DORA
the
EXPLORER™

NET WT
4.6 OZ
(130 g)

Mild BUBBLE FRUIT® FLAVOR

Principal Display Panel - 130 g Tube Label
COLGATE   JUNIOR DORA
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-534
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE0.24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL476 mg  in 1 g
WATER 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 600 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM DIHYDRATE 
MICA 
TITANIUM DIOXIDE 
FD&C RED NO. 40 
D&C RED NO. 33 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-534-46130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/2011
Labeler - Mission Hills, S.A. de C.V. (812312122)

Revised: 01/2012
Document Id: 190622a1-f274-4595-8656-83164076d145
Set id: b2ca5eb7-b014-4f48-8280-09429426fbc8
Version: 1
Effective Time: 20120124
 
Mission Hills, S.A. de C.V.