BIOTENE SENSITIVE - potassium nitrate and sodium monofluorophosphate paste
GlaxoSmithKline Consumer Healthcare LP

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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Active ingredients

Potassium nitrate (5.0%)

Sodium Monofluorophosphate (014% w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

builds increasing protection against painful sensitivity of the teeth due to cold, heat , acids, sweets, or contact
aids in the prevention of dental cavities

Warnings

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Stop use and ask a dentist if

the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older
- apply at least a 1-inch strip of the product onto a soft bristle toothbrush
- brush teeth thoroughly for at least one minute, preferable after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
Children under 12 years of age: consult a dentist or physician

Other Information

store below 25°C (77°F)

Inactive ingredients

acesulfame K, calcium lactate, calcium pyrophosphate, cellulose gum, flavor, beta-D-glucose, glycerin, hydrated silica, isoceteth-20, lactoferrin, potassium thiocyanate, purified water, sodium benzoate, sorbitol, xylitol. Enzyme System: glucose oxidase, lactoperoxidase, lysozyme

Questions or comments?

call toll-free 1-800-922-5856 weekdays

Principal Display Panel

biotene®

Sensitive

MULTI-PROTECTION FORMULA

Fluoride Toothpaste for SENSITIVE TEETH & Cavity Prevention

Relieves Pain & Discomfort

WITH GENTLE DRY MOUTH PROTECTION

NET WT 3.5 OZ (99.2g)

#1 DENTIST & HYGIENIST RECOMMENDED BRAND FOR DRY MOUTH

#1 RECOMMENDED DRY MOUTH BRAND

Supplements saliva's natural defenses and strengthens teeth

With Regular Brushing

Builds Increasing protection against painful sensitivty.
Maximum Strength formula soothes the nerves in your teeth where dentis is exposed.
Clinically Proven to relieve dry mouth*
Gentle Formula does not contain sodium lauryl sulfate.
PATENTED SALIVARY LP3™ ENZYME SYSTEM

*when used in combination with oralbalance® Gel

TRIPLE ENZYME PROTECTION

Lactoperoxidase
Glucose Oxidase
Lysozyme

biotene® Sensitive Toothpaste combines #1 recommended ingredient to reduce painful sensitivity with #1Dentist &Hygienist Recommened Brand for Dry Mouth

Helpful to dry mouth sufferers having difficulties maintaining good oral hygiene

This product contains no saccharin.

No sodium lauryl sulfate (SLS)

biotene®, oralbalance®, Salivary LP3 Enzyme System™ and various graphic elements are trademarks of the GlaxoSmithKline group of companies.

Xylitol® is a trademark of Danisco Sweetners Oy

www.biotene.com

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Naturally sweetened with Xylitol®

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Biotene Sensitive carton

BIOTENE SENSITIVE
potassium nitrate and sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0489
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (POTASSIUM CATION)	POTASSIUM CATION	19.3 mg in 1 g
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION)	FLUORIDE ION	1 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM
CALCIUM LACTATE
CALCIUM PYROPHOSPHATE
CARBOXYMETHYLCELLULOSE SODIUM
.BETA.-D-GLUCOPYRANOSE
GLYCERIN
HYDRATED SILICA
CETETH-20
TALACTOFERRIN ALFA
POTASSIUM THIOCYANATE
WATER
SODIUM BENZOATE
SORBITOL
XYLITOL
GLUCOSE OXIDASE
LACTOPEROXIDASE BOVINE
LYSOZYME, CHICKEN EGG WHITE

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

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0135-0489-01	1 TUBE ( TUBE) in 1 CARTON	contains a TUBE
1		99.2 g in 1 TUBE	This package is contained within the CARTON (0135-0489-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/15/2011

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 04/2011 GlaxoSmithKline Consumer Healthcare LP