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 olderbrush teeth thoroughly, preferably after each meal or 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, 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-564
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL665.38 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
ColorBLUEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-564-81130 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/06/2008
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 2/2014
Document Id: 11d0b755-0233-46b7-a668-d6a538ec2f24
Set id: 93c443bd-bb73-40a7-bdb0-0d7283220e39
Version: 2
Effective Time: 20140224
 
Mission Hills S.A de C.V