COLGATE  BAKING SODA AND PEROXIDE WHITENING BRISK MINT- sodium monofluorophosphate paste, 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% (0.14% 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

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Carton

Colgate®
Fluoride Toothpaste

NET WT 4.6 OZ (130 g)

Baking Soda
& Peroxide
Whitening

Cleans Deep and
Whitens Teeth

Brisk Mint®Paste

PRINCIPAL DISPLAY PANEL - 130 g Cartonl
COLGATE   BAKING SODA AND PEROXIDE WHITENING BRISK MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-765
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
GLYCERIN491.6 mg  in 1 g
HYDRATED SILICA 
WATER 
SODIUM BICARBONATE 
POLYETHYLENE GLYCOL 600 
SODIUM LAURYL SULFATE 
SODIUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
CARRAGEENAN 
SACCHARIN SODIUM 
CALCIUM PEROXIDE 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-765-461 in 1 CARTON
1130 g in 1 TUBE
2NDC:65954-765-641 in 1 CARTON
2181 g in 1 TUBE
3NDC:65954-765-821 in 1 CARTON
3232 g in 1 TUBE
4NDC:65954-765-691 in 1 CARTON
4113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/20/2011
Labeler - Mission Hills, S.A. de C.V. (812312122)

Revised: 03/2013
Document Id: 3b466cc9-91d7-49c6-87d6-09469a6ea914
Set id: 40fa39f5-27a0-4d36-ad0a-fb2931e4b117
Version: 2
Effective Time: 20130314
 
Mission Hills, S.A. de C.V.