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.

----------

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

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

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

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