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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
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 Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 11/11/2016
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 11/2016
Document Id: f0a98511-7787-4a3c-badc-8e5a3782ff63
Set id: be965c17-a82a-4d03-b30d-dcee6da6204c
Version: 5
Effective Time: 20161110
 
Mission Hills S.A de C.V