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 the 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 olderbrush teeth thoroughly, preferably after each meal at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask 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

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
Made in Mexico
www.colgatemaxfresh.com

PRINCIPAL DISPLAY PANEL - 221 g Carton

Infused with Dissolvable Mini Breath Strips

Colgate®
Fluoride Toothpaste

MaxFresh®
WITH
MINI BREATH STRIPS

WHITENING
COOL MINT

NET WT 7.8 OZ (221 g)

Experience a Whole New Dimension of Freshness

Principal Display Panel - 221 g Carton
COLGATE MAX FRESH 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-013
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.4 mg  in 1 g
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-013-601 in 1 CARTON
1221 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/04/2010
Labeler - Mission Hills S.A. de C.V. (812312122)

Revised: 04/2010
Document Id: 5701eb2f-a701-4b25-8948-86db124bf905
Set id: 2df00ac3-b22b-439f-bbb8-d964079076b6
Version: 1
Effective Time: 20100414
 
Mission Hills S.A. de C.V.