COLGATE  2IN1 OXYGEN WHITENING COOL MINT FLUORIDE- sodium monofluorophosphate 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 monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of cavities

Warnings

Keep out of the 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

glycerin, hydrated silica, propylene glycol, water, sorbitol, sodium lauryl sulfate, flavor, sodium bicarbonate, sodium hydroxide, sodium saccharin, cellulose gum, polyethylene, carrageenan, calcium peroxide, titanium dioxide, FD&C blue no. 1

Questions?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130g Bottle Label

2 in 1
Toothpaste
& Mouthwash

Colgate®
Fluoride Toothpaste

Cleans Teeth & Freshens Breath

Oxygen
Whitening

Cool Mint

NET WT 4.6 OZ(130g)
LIQUID GEL

Principal Display Panel - 130g Bottle Label
COLGATE   2IN1 OXYGEN WHITENING COOL MINT FLUORIDE
sodium monofluorophosphate gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-372
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL634.68 mg  in 1 g
WATER 
GLYCERIN 
HYDRATED SILICA 
HIGH DENSITY POLYETHYLENE 
SODIUM LAURYL SULFATE 
PROPYLENE GLYCOL 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN SODIUM 
SODIUM BICARBONATE 
SODIUM HYDROXIDE 
CARRAGEENAN 
CALCIUM PEROXIDE 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-372-81130 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/26/2011
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 05/2013
Document Id: 28d0d52b-f78c-48a7-8852-a8c44a445862
Set id: 58360dd2-e670-434e-a67e-85aa4a5db2a8
Version: 1
Effective Time: 20130529
 
Mission Hills S.A de C.V