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.

----------

Colgate® Max Fresh® Cool Mint Fluoride Toothpaste

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 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, 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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Bursting with Freshness That Lasts for Hours

Colgate®
Fluoride Toothpaste

MaxFresh®
WITH
MINI BREATH STRIPS

WHITENING

COOL MINT

NET WT 6.0 OZ (170 g)

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
COLGATE   MAX FRESH COOL MINT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-014
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
SORBITOL564.38 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 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-014-601 in 1 CARTON
1170 g in 1 TUBE
2NDC:65954-014-011 in 1 CARTON
228.3 g in 1 TUBE
3NDC:65954-014-751 in 1 CARTON
379 g in 1 TUBE
4NDC:65954-014-781 in 1 CARTON
4221 g in 1 TUBE
5NDC:65954-014-991 in 1 CARTON
553 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/01/2011
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 7/2013
Document Id: e42ecebb-8634-4d73-adf4-a4244a804b7b
Set id: d142e43f-415a-41c5-a7db-8b18a039a323
Version: 5
Effective Time: 20130710
 
Mission Hills S.A de C.V