COLGATE JUNIOR BUBBLE FRUIT- sodium fluoride gel, 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 older	brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years	use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years	ask 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 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®
Fluoride Toothpaste

ADA
Accepted
American
Dental
Association ®

NET WT 2.7 OZ (76 g)

Kids
Clinically Proven
Cavity
Protection

Bubble Fruit® Flavor

Principal Display Panel - 76 g Tube Carton

COLGATE JUNIOR BUBBLE FRUIT
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-327
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	1.1 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL	476 mg in 1 g
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
SACCHARIN SODIUM
MICA
TITANIUM DIOXIDE
FD&C BLUE NO. 1

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:65954-327-59	1 in 1 CARTON
1		76 g in 1 TUBE
2	NDC:65954-327-20	1 in 1 CARTON
2		24 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	12/01/2011

Labeler - Mission Hills S.A de C.V (812312122)

Revised: 05/2013

Document Id: 898dcb6f-b499-4916-96ee-1d580fab9e7b

Set id: be965c17-a82a-4d03-b30d-dcee6da6204c

Version: 3

Effective Time: 20130530

Mission Hills S.A de C.V