COLGATE MAX CLEAN EFFERVESCENT MINT - 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% (0.14% 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

water, sorbitol, hydrated silica, PEG-12, poloxomer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, polyethylene, mica, titanium dioxide, methylcellulose, FD&C blue no. 1, FD&C blue no. 1 lake

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 204 g Carton

Penetrates Hard to Reach Places for a Rush of Clean*

Colgate®
Fluoride Toothpaste

NEW

MaxClean™
SMARTFOAM™
WITH WHITENING

Effervescent Mint™

20%
FREE
6.0 oz + 1.2 oz

NET WT 7.2 OZ (204 g)

COLGATE MAX CLEAN EFFERVESCENT MINT
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-381
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	347 mg in 1 g
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
POLOXAMER 407
SODIUM LAURYL SULFATE
XANTHAN GUM
COCAMIDOPROPYL BETAINE
SODIUM PYROPHOSPHATE
MICA
TITANIUM DIOXIDE
SACCHARIN SODIUM DIHYDRATE
FD&C BLUE NO. 1

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:65954-381-85	1 TUBE ( TUBE) in 1 CARTON	contains a TUBE
1		204 g in 1 TUBE	This package is contained within the CARTON (65954-381-85)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	08/01/2011

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

Revised: 01/2012 Mission Hills, S.A. de C.V.