COLGATE MAX FRESH- 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, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1, FD&C yellow no. 5

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®

Anticavity

Fluoride Toothpaste

Bursting with Freshness That Lasts for Hours!

WITH WHITENING

maxFresh®

WITH
MINI BREATH STRIPS

CLEAN MINT

NET WT 6.0 OZ (170 g)

Principal Display Panel - 170 g Tube Carton

COLGATE MAX FRESH
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-013
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	564.38 mg in 1 g
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM PYROPHOSPHATE
COCAMIDOPROPYL BETAINE
SACCHARIN SODIUM
POWDERED CELLULOSE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5

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

Packaging
#	Item Code	Package Description
1	NDC:65954-013-60	1 in 1 CARTON
1		170 g in 1 TUBE

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: 06/2013

Document Id: e995c4b3-a569-4fad-b3a4-f221cf1c94a0

Set id: 2df00ac3-b22b-439f-bbb8-d964079076b6

Version: 3

Effective Time: 20130613

Mission Hills, S.A. de C.V.