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Colgate Junior Bubble Fruit

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 1.1mg in 1g
Labeler: Mission Hills S.A de C.V
NDC Code: 65954-327

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® JUNIOR BUBBLE FRUIT® 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, D&C yellow no. 10, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 76 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

Kids
Cavity
Protection
Bubble Fruit® Flavor

Fights Cavities
Clinically Proven
Enamel Safe

ADA
Accepted
American
Dental
Association ®

NET WT 2.7 OZ (76 g)

COLGATE JUNIOR BUBBLE FRUIT 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-327
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL476 mg  in 1 g
WATER 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 600 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
SODIUM LAURYL SULFATE 
SACCHARIN SODIUM 
MICA 
TITANIUM DIOXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-327-591 TUBE in 1 CARTON
176 g in 1 TUBE
2NDC:65954-327-201 TUBE in 1 CARTON
224 g in 1 TUBE
3NDC:65954-327-461 TUBE in 1 CARTON
3130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/11/2016
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 11/2016
 
Mission Hills S.A de C.V

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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