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.

----------

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.

Moon Township, PA 15108 ©2010 GlaxoSmithKline

Naturally sweetened with Xylitol®

000000XX

Biotene Sensitive carton

BIOTENE  SENSITIVE
potassium nitrate and sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0489
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (POTASSIUM CATION) POTASSIUM CATION19.3 mg  in 1 g
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0489-011 in 1 CARTON
199.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/15/201101/31/2013
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 09/2011
 
GlaxoSmithKline Consumer Healthcare LP