COLGATE  MAX CLEAN EFFERVESCENT 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 Clean™ Effervescent mint™ 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

water, sorbitol, hydrated silica, PEG-12, poloxamer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, methylcellulose, mica, titanium dioxide, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

Colgate®
Anticavity Fluoride Toothpaste

30% More Foam*
Cleans Tough to Reach Spaces

NET WT 6.0 OZ (170 g)

WITH WHITENING
MaxClean

SMARTFOAM®

EFFERVESCENT MINT™

Principal Display Panel - 170 g Tube Label
COLGATE   MAX CLEAN EFFERVESCENT MINT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-381
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
SORBITOL347 mg  in 1 g
WATER 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 600 
POLOXAMER 407 
SODIUM LAURYL SULFATE 
XANTHAN GUM 
COCAMIDOPROPYL BETAINE 
SODIUM PYROPHOSPHATE 
MICA 
TITANIUM DIOXIDE 
SACCHARIN SODIUM 
METHYLCELLULOSE (400 MPA.S) 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-381-011 in 1 CARTON
128.3 g in 1 TUBE
2NDC:65954-381-601 in 1 CARTON
2170 g in 1 TUBE
3NDC:65954-381-851 in 1 CARTON
3204 g in 1 TUBE
4NDC:65954-381-781 in 1 CARTON
4221 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/18/2011
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 7/2013
Document Id: 4fc4a24d-a1af-4c9d-983c-460a07b7e1cb
Set id: 649caacc-b81e-4a94-9cc3-69f5d378caef
Version: 3
Effective Time: 20130712
 
Mission Hills S.A de C.V