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Name:Biotenesensitive
Manufacturer:Glaxosmithkline Consumer Healthcare Lp
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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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Drug Facts

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 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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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