BRITESMILE WHITENING- sodium fluoride paste, dentifrice
Discus Dental, LLC

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 fluoride (0.24%)

Purpose

Anticavity toothpaste

Use

aids in the prevention of dental decay

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

do not swallow supervise children as necessary until capable of using without supervision

adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years ask a dentist or physician

Inactive ingredients

WATER, HYDRATED SILICA, GLYCERIN, SORBITOL, SODIUM TRIPOLYPHOSPHATE, POVIDONE, TITANIUM DIOXIDE, CARBOXYMETHYLCELLULOSE, SODIUM LAURYL SULFATE, SODIUM METHYL COCOYL TAURATE, SODIUM BENZOATE, SACCHARIN, SODIUM HYDROXIDE

Questions or comments?

Call: 1-800-422-9448

ANTICAVITY FLUORIDE TOOTHPASTE

BriteSmile

WHITENING TOOTHPASTE
NET WT. 4.2 OZ. (119g)

Carton image

BRITESMILE WHITENING
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64854-035
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN (UNII: FST467XS7D)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64854-035-01	1 in 1 PACKAGE	10/05/2011	12/31/2016
1		119 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/26/2006	12/31/2016

Labeler - Discus Dental, LLC (831726109)

Registrant - Discus Dental, LLC (831726109)

Revised: 9/2012

Document Id: 1fa3a488-0b5d-44ee-94c3-b68d88de46e1

Set id: fa944b82-a68a-4d77-9ba0-94214c51c34d

Version: 2

Effective Time: 20120928

Discus Dental, LLC