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 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

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

COLGATE BAKING SODA AND PEROXIDE WHITENING BRISK MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-765
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION)	SODIUM MONOFLUOROPHOSPHATE	7.6 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN	491.6 mg in 1 g
HYDRATED SILICA
WATER
SODIUM BICARBONATE
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
SODIUM HYDROXIDE
CARBOXYMETHYLCELLULOSE SODIUM
CARRAGEENAN
SACCHARIN SODIUM DIHYDRATE
CALCIUM PEROXIDE
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:65954-765-46	1 in 1 CARTON
1		130 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	08/20/2011

Labeler - Mission Hills, S.A. de C.V. (812312122)

Revised: 01/2012

Document Id: aeb8a45d-9ea6-4d71-b586-460290f4becb

Set id: 40fa39f5-27a0-4d36-ad0a-fb2931e4b117

Version: 1

Effective Time: 20120127

Mission Hills, S.A. de C.V.