COLGATE KIDS MILD BUBBLE FRUIT FLAVOR- 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 - 99 g Tube Label

Colgate®
Fluoride Toothpaste

CLINICALLY PROVEN
Cavity & Enamel Protection

ADA
Accepted
American
Dental
Association ®

Kids

NET WT 3.5 OZ (99g)

Toothpaste

Mild BUBBLE FRUIT® FLAVOR

PRINCIPAL DISPLAY PANEL - 99 g Tube Label

COLGATE KIDS MILD BUBBLE FRUIT FLAVOR
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-065
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:65954-065-93	24 g in 1 TUBE

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

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

Revised: 01/2013

Document Id: eec65034-e4f8-4aa3-966c-cba339cca449

Set id: 39247381-c565-4e43-8174-f3d9a58b4625

Version: 1

Effective Time: 20130131

Mission Hills S.A de C.V