Your browser does not support JavaScript! COLGATE MAXFRESH FRESH MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]
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RxNorm Names

COLGATE MAXFRESH FRESH MINT (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

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

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, tetrasodium pyrophosphate, flavor, cocamidopropyl betaine, sodium saccharin, cellulose gum, xanthan gum, 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 - 130 g Bottle Label

1D

Colgate®

Fluoride Toothpaste

1D

Fresh Mint

NET WT 4.6 OZ (130g) LIQUID GEL

Principal Display Panel - 130 g Bottle Label
COLGATE MAXFRESH FRESH MINT 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-010
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
SORBITOL670 mg  in 1 g
WATER 
HYDRATED SILICA 
POLYETHYLENE GLYCOL 600 
SODIUM LAURYL SULFATE 
SODIUM PYROPHOSPHATE 
COCAMIDOPROPYL BETAINE 
SACCHARIN SODIUM 
CARBOXYMETHYLCELLULOSE SODIUM 
XANTHAN GUM 
MICA 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-010-81130 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/08/2013
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 2/2014
 
Mission Hills S.A de C.V

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