COLGATE  MAX FRESH INTENSE- sodium fluoride paste, 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®

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 of physician

Inactive ingredients

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, zinc oxide, methylcellulose, FD&C blue no. 1, D&C red no. 33

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 1002

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

NEW INTENSE FRESHNESS

Max Fresh®
WITH
GERM-FIGHTING STRIPS

Removes 90% of
Odor Causing Bacteria!*

INTENSE MINT WITH WHITENING

NET WT 6.0 OZ (170 g)

Principal Display Panel - 170 g Tube Carton
COLGATE   MAX FRESH INTENSE
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-554
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 
ZINC OXIDE 
METHYLCELLULOSE (25 MPA.S) 
FD&C BLUE NO. 1 
D&C RED NO. 33 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-554-601 in 1 CARTON
1170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/08/2011
Labeler - Mission Hills S.A. de C.V. (812312122)

Revised: 7/2013
Document Id: a19871fe-1e30-41f3-b98a-3906b3e86e4f
Set id: c9bb958f-214c-4229-8660-5b2a19c0cd6c
Version: 3
Effective Time: 20130712
 
Mission Hills S.A. de C.V.