COLGATE  JUNIOR BUBBLEFRUIT- 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®
JUNiOR
Bubble Fruit®

Drug Facts

Active ingredients

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, flavor, sodium lauryl sulfate, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 70 g Carton

Colgate®
Anticavity Fluoride Toothpaste

ADA
Accepted

American
Dental
Association ®

NET WT 2.5 OZ (70 g)

JUNiOR
Bubble Fruit
®
Flavor

Principal Display Panel - 70 g Carton
COLGATE   JUNIOR BUBBLEFRUIT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-327
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)  
titanium dioxide (UNII: 15FIX9V2JP)  
FD&C Blue no. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUE (Pearlescent) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51442-327-5870 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: 7/2011
Document Id: 3ef80ca8-79fd-4e32-9319-f48ecbe3e8d3
Set id: 915c259a-6cad-4886-b8cb-c1ab8939d85c
Version: 1
Effective Time: 20110727
 
Colgate-Palmolive Canada