COLGATE MAX CLEAN SPEARMINT BLAST- 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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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, poloxomer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, polyethylene, mica, titanium dioxide, iron oxides, methylcellulose, FD&C blue no. 1, FD&C blue no. 1 lake, D&C yellow no. 10 lake

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
www.colgate.com/maxclean
Made in Mexico

PRINCIPAL DISPLAY PANEL - 170 g Carton

Penetrates Hard to Reach Places for a Rush of Clean*

Colgate®
Anticavity Fluoride Toothpaste

NET WT 6.0 OZ (170 g)

NEW
MaxClean

SMARTFOAM
WHITENING

Spearmint Blast™

Principal Display Panel - 170 g Carton
COLGATE MAX CLEAN  SPEARMINT BLAST
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-382
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER243.8 mg  in 1 g
SORBITOL347 mg  in 1 g
HYDRATED SILICA240 mg  in 1 g
POLYETHYLENE GLYCOL 60030 mg  in 1 g
POLOXAMER 40720 mg  in 1 g
SODIUM LAURYL SULFATE51.72 mg  in 1 g
XANTHAN GUM8.5 mg  in 1 g
COCAMIDOPROPYL BETAINE25 mg  in 1 g
SODIUM PYROPHOSPHATE5 mg  in 1 g
MICA3.4 mg  in 1 g
TITANIUM DIOXIDE0.56 mg  in 1 g
SACCHARIN SODIUM4 mg  in 1 g
FD&C BLUE NO. 10.00125 mg  in 1 g
D&C YELLOW NO. 100.01 mg  in 1 g
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-382-601 in 1 CARTON
1170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/2010
Labeler - Mission Hills, S.A. de C.V. (812312122)

Revised: 12/2010
 
Mission Hills, S.A. de C.V.