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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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 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, 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)

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)	476 mg in 1 g
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65954-327-59	1 in 1 CARTON	11/11/2016
1		76 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:65954-327-20	1 in 1 CARTON	11/11/2016
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:65954-327-46	1 in 1 CARTON	11/11/2016
3		130 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	11/11/2016

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

Revised: 4/2019

Document Id: 9a67a37f-be0d-43b7-a3fe-560399fa0fe8

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

Version: 6

Effective Time: 20190405

Mission Hills S.A de C.V