Your browser does not support JavaScript! COLGATE MAX CLEAN SPEARMINT BLAST (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]
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RxNorm Names

COLGATE MAX CLEAN SPEARMINT BLAST (sodium fluoride) gel, dentifrice
[Mission Hills S.A de C.V]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
  • Children under 2 years: Ask 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, FD&C yellow no. 5

Questions?

1-800-468-6502
www.colgate.com/maxclean

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Label

Colgate®
Anticavity Fluoride Toothpaste

WITH WHITENING
MaxClean™
SMARTFOAM®

30% More Foam*
Cleans Tough to Reach Spaces

SPEARMINT BLAST®

NET WT 6.0 OZ (170 g)

Principal Display Panel - 170 g Tube Label
COLGATE MAX CLEAN   SPEARMINT BLAST
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-382
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 
FERRIC OXIDE RED 
POWDERED CELLULOSE 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-382-851 in 1 CARTON
1204 g in 1 TUBE
2NDC:65954-382-601 in 1 CARTON
2170 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
 
Mission Hills S.A de C.V

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