Colgate Max Clean Effervescent Mint

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 1.1mg in 1g
Labeler: Mission Hills S.A de C.V
NDC Code: 65954-381

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 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™

COLGATE   MAX CLEAN EFFERVESCENT MINT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:65954-381-011 TUBE in 1 CARTON
128.3 g in 1 TUBE
2NDC:65954-381-601 TUBE in 1 CARTON
2170 g in 1 TUBE
3NDC:65954-381-851 TUBE in 1 CARTON
3204 g in 1 TUBE
4NDC:65954-381-781 TUBE 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: 07/2013
 
Mission Hills S.A de C.V

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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