COLGATE MAX FRESH COOL 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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Colgate® Max Fresh® Cool Mint 4.6oz 2in1 Fluoride Toothpaste

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

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, xanthan gum, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

WITH WHITENING

MaxFresh®

WITH
MINI
BREATH STRIPS

Colgate®
Anticavity Fluoride Toothpaste

Bursting with
Freshness that
Lasts for Hours!

COOL
MINT

NET WT 4.6 OZ (130 g)

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

COLGATE MAX FRESH COOL MINT
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:65954-564
Route of Administration	DENTAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
SORBITOL	665.38 mg in 1 g
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
SODIUM PYROPHOSPHATE
XANTHAN GUM
COCAMIDOPROPYL BETAINE
SACCHARIN SODIUM
METHYLCELLULOSE (100 MPA.S)
FD&C BLUE NO. 1

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65954-564-81	130 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	04/06/2008

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

Revised: 1/2013

Document Id: fdd5f240-7a45-49bb-a5d1-3023e69dadc9

Set id: 93c443bd-bb73-40a7-bdb0-0d7283220e39

Version: 1

Effective Time: 20130109

Mission Hills S.A de C.V