COLGATE KIDS HALLOWEEN WICKED WATERMELON- 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, glycerin, hydrated silica, PEG-12, sodium lauryl sulfate, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, flavor, xanthan gum, FD&C blue no. 1, FD&C yellow no. 5

Questions?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130g Bottle Label

GLOW in the DARK

Colgate®

Clinically Proven Cavity and Enamel Protection
Fluoride Toothpaste

wicked
watermelon
flavor

NET WT 4.6 OZ (130g) LIQUID GEL

Principal Display Panel - 130g Bottle Label

COLGATE KIDS HALLOWEEN WICKED WATERMELON
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-504
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	SODIUM FLUORIDE	2.4 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL	646.15 mg in 1 g
GLYCERIN	129.99 mg in 1 g
HYDRATED SILICA	117.99 mg in 1 g
POLYETHYLENE GLYCOL 600	13.99 mg in 1 g
SODIUM LAURYL SULFATE	17.24 mg in 1 g
COCAMIDOPROPYL BETAINE	12.5 mg in 1 g
SODIUM PYROPHOSPHATE	5 mg in 1 g
SACCHARIN SODIUM	3.15 mg in 1 g
XANTHAN GUM	2.2 mg in 1 g
FD&C BLUE NO. 1	0.018 mg in 1 g
FD&C YELLOW NO. 5	0.013 mg in 1 g

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

Packaging
#	Item Code	Package Description
1	NDC:65954-504-81	130 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	07/26/2011

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

Revised: 07/2011

Document Id: e7db85d9-f79d-43f3-b090-6e8cecb5d5cf

Set id: 8f1b4446-721e-461a-af6b-0cccace85ce2

Version: 1

Effective Time: 20110728

Mission Hills S.A. de C.V.