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


Drug Facts

BIOTENE - sodium monofluorophosphate paste 
BIOTENE FRESH MINT ORIGINAL - sodium monofluorophosphate paste 
BIOTENE GENTLE MINT - sodium monofluorophosphate gel 
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 ingredient

Sodium monofluorophosphate (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children 12 years and under.

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional.

Directions

Adults and children over 12 years

  • apply toothpaste onto a soft bristle toothbrush
  • brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established.

Other Information

store below 25°C (77F°)

Inactive ingredients (PBF Dry Mouth)

Sorbitol, Glycerin, Water, Silica, Xylitol, Hydrated Silica, Isoceteth-20, Poloxamer 188, Cellulose Gum, Flavor, Sodium Benzoate, Mutanase, Lactoperoxidase, Potassium Thiocyanate, Glucose Oxidase, Mica, Titanium Dioxide, Lysozyme, Lactoferrin, Dextranase, Chlorophyllin-Copper Complex, Calcuim Lactate. Contains milk and egg derivatives.

Inacitve Ingredients (Fresh Mint Original)

Sorbitol, Glycerin, Calcium Pyrophosphate, Water, Hydrated Silica, Xylitol, Silica, Hydroxyethylcellulose, Isoceteth-20, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, glucose Oxidase, Lysozyme, Lactoferrin, Calcium Lactate. Contains milk and egg derivatives.

Inactive Ingredients (Gentle Mint)

Sorbitol, glycerin, Water, Silica, Xylitol, Hydrated Silica, Isoceteth-20, Poloxamer 188, Cellulose Gum, Flavor, Sodium Benzoate, Lactoperoxidase, Potassium Thiocyanate, Glucose Oxidase, Lysozyme, Lactoferrin, Calcium Lactate, Blue 1. Contains milk and egg derivatives.

Questions or comments?

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

Principal Display Panel

NDC 0135-0490-01

biotene®

with Xylitol®

PBF DRY MOUTH

FLUORIDE TOOTHPASTE

  • Plaque-BioFilm Loosening Formula
  • Protein-Enzyme System
  • Fights Cavities

Helps Loosen Plaque-BioFilm*

#1 DENTIST & HYGIENIST RECOMMENDED BRAND FOR DRY MOUTH

  • Formulated to Not Irritate a Dry Mouth
  • Gentle, Low Foaming Formula
  • Freshens Breath

* with regular brushing

NET WT 4.5 OZ (127.6G)

BioFilm is the bacterial film on your tetth often described as plaque. With a dry mouth, saliva's natural ability to cleanse and control BioFilm is reduced.

With two additional enzymes, biotene® PBF Toothpastes' patented technology helps loosen the BioFilm.

Like Original biotene® Toothpaste, biotene® PBF Toothpaste also contains a Protein-Enzyme system to help maintain the oral environment.

www.biotene.com

 Naturraly Sweetened with Xylitol®

SLS-Free

BIOTENE is a registered trademark of the GlaxoSmithKline group of companies.

XYLITOL is a trademark of the Danisco Sweetners Oy.

Distributed By:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2011 GlaxoSmithKline

30754XB

Biotene PBF carton

Principal Display Panel (Fresh Mint Original)

NDC 0135-0487-01

biotene®

Protein-Enzyme System

DRY MOUTH

FLUORIDE TOOTHPASTE

Gentle, Low Foaming Formula

Formulated to Not Irritate a Dry Mouth

FRESH MINT ORIGINAL

NET WT 4.5 OZ (127.6g)

#1 RECOMMENDED DRY MOUTH BRAND

Helps Maintain Oral Environment

  • Helps Prevent Cavities
  • Formulated to Not Irritate a Dry Mouth
  • Detergent Free (No SLS)
  • Low Foaming, Mild Flavor
  • Freshens Bad Breath

#1 Dentist & Hygienist Recommended Brand for Dry Mouth

You may not realize you suffer from dry mouth symptoms until it causes dental problems. If you are experiencing some of the following problems, it may be due to a dry mouth.

  • Constant dry feeling
  • Sore or bleeding gums
  • Cracked lips
  • Bad breath
  • Cavities

Dry mouth is commonly associated with the use of medications.

Over 400 commonly used drugs may reduce your saliva flow.

Biotene® Dry Mouth Toothpaste contains beneficial enzymes found in saliva and helps dry mouth sufferers maintain the oral environment and good oral hygiene.

This product contains no saccharin.

No sodium lauryl sulfate (SLS)

BIOTENE and LP3 are trademarks of the GlaxoSmithKline group of companies.

XYLITOL is a registered trademark of Danisco Sweetners Oy.

www.biotene.com

Naturally Sweetened with Xylitol®

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2011 GlaxoSmithKline

100939XA

Biotene Fresh Mint Original carton

Principal Display Panel (Gentle Mint Gel)

NDC 0135-0488-01

biotene®

Protein-Enzyme System

DRY MOUTH

FLUORIDE TOOTHPASTE

Gentle, Low Foaming Formula

Formulated to Not Irritate a Dry Mouth

GENTLE MINT GEL

NET WT 4.5 OZ (127.6g)

#1 RECOMMENDED DRY MOUTH BRAND

Helps Maintain Oral Environment

  • Helps Prevent Cavities
  • Formulated to Not Irritate a Dry Mouth
  • Detergent Free (No SLS)
  • Low Foaming, Mild Flavor
  • Freshens Bad Breath

#1 Dentist & Hygienist Recommended Brand for Dry Mouth

You may not realize you suffer from dry mouth symptoms until it causes dental problems. If you are experiencing some of the following problems, it may be due to a dry mouth.

  • Constant dry feeling
  • Sore or bleeding gums
  • Cracked lips
  • Bad breath
  • Cavities

Dry mouth is commonly associated with the use of medications.

Over 400 commonly used drugs may reduce your saliva flow.

Biotene® Dry Mouth Toothpaste contains beneficial enzymes found in saliva and helps dry mouth sufferers maintain the oral environment and good oral hygiene.

This product contains no saccharin.

No sodium lauryl sulfate (SLS)

BIOTENE and LP3 are trademarks of the GlaxoSmithKline group of companies.

XYLITOL is a registered trademark of Danisco Sweetners Oy.

www.biotene.com

Naturally Sweetened with Xylitol®

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2011 GlaxoSmithKline

100929XA

Biotene Gentle Mint Gel carton


BIOTENE 
sodium monofluorophosphate paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0490
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 0.76 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL  
GLYCERIN  
WATER  
SILICON DIOXIDE  
XYLITOL  
HYDRATED SILICA  
CETETH-20  
POLOXAMER 188  
CARBOXYMETHYLCELLULOSE SODIUM  
SODIUM BENZOATE  
MUTANASE SCHIZOSACCHAROMYCES POMBE  
LACTOPEROXIDASE BOVINE  
POTASSIUM THIOCYANATE  
GLUCOSE OXIDASE  
MICA  
TITANIUM DIOXIDE  
LYSOZYME, CHICKEN EGG WHITE  
TALACTOFERRIN ALFA  
DEXTRANASE PENICILLIUM  
SODIUM COPPER CHLOROPHYLLIN  
CALCIUM LACTATE  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0490-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 127.6 g in 1 TUBE This package is contained within the CARTON (0135-0490-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 04/18/2011

BIOTENE  FRESH MINT ORIGINAL
sodium monofluorophosphate paste
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0487
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 0.76 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL  
GLYCERIN  
CALCIUM PYROPHOSPHATE  
WATER  
HYDRATED SILICA  
XYLITOL  
SILICON DIOXIDE  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
CETETH-20  
CARBOXYMETHYLCELLULOSE SODIUM  
SODIUM BENZOATE  
LACTOPEROXIDASE BOVINE  
POTASSIUM THIOCYANATE  
GLUCOSE OXIDASE  
LYSOZYME, CHICKEN EGG WHITE  
TALACTOFERRIN ALFA  
CALCIUM LACTATE  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor MINT (Fresh Mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0487-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 127.6 g in 1 TUBE This package is contained within the CARTON (0135-0487-01)
2 NDC:0135-0487-02 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
2 21.3 g in 1 TUBE This package is contained within the CARTON (0135-0487-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 04/18/2011

BIOTENE  GENTLE MINT
sodium monofluorophosphate gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0488
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION 0.76 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL  
GLYCERIN  
WATER  
SILICON DIOXIDE  
XYLITOL  
HYDRATED SILICA  
CETETH-20  
POLOXAMER 188  
CARBOXYMETHYLCELLULOSE SODIUM  
SODIUM BENZOATE  
LACTOPEROXIDASE BOVINE  
POTASSIUM THIOCYANATE  
GLUCOSE OXIDASE  
LYSOZYME, CHICKEN EGG WHITE  
TALACTOFERRIN ALFA  
CALCIUM LACTATE  
FD&C BLUE NO. 1  
Product Characteristics
Color GREEN (blue green) Score     
Shape Size
Flavor MINT (Gentle mint) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0488-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 127.6 g in 1 TUBE This package is contained within the CARTON (0135-0488-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 04/18/2011

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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