BIOTENE FRESH MINT ORIGINAL- sodium fluoride paste 
BIOTENE GENTLE MINT- sodium fluoride paste 
BIOTENE PBF- sodium fluoride 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 ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children 12 years of age 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. Do not use if you are allergic to any of the ingredients.

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 (Fresh Mint Original)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide

Inactive Ingredients (Gentle Mint)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, D&C Yellow #10, FD&C Blue #1

Inactive Ingredients (PBF)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, Dextranase, D&C Yellow #10, FD&C Blue #1

Questions or comments?

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

Principal Display Panel

NDC 0135-0557-01

biotene®

ESSENTIAL FLUORIDE TOOTH PROTECTION

DRY MOUTH

FLUORIDE TOOTHPASTE

Gentle Formula

Designed to Not Irritate a Dry Mouth

NEW Improved pH Balance

FRESH MINT ORIGINAL

NET WT 4.3 OZ (121.9g)

#1 RECOMMENDED DRY MOUTH BRAND

Helps Maintain Oral Environment

Helps Prevent Cavities
Designed to Not Irritate a Dry Mouth
SLS Free
Mild Flavor
Helps Freshen Bad Breath

#1 Dentist & Hygienist Recommended Brand for Dry Mouth

If you suffer from dry mouth you may be experiencing some of these problems.

Constant dry feeling
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.

With brushing biotene® toothpaste helps maintain a healthy oral environment and provides essential fluoride tooth protection for dry mouth sufferers or for people who need mild toothpaste.

ALWAYS FOLLOW THE LABEL

This product contains no Sodium Lauryl Sulfate (SLS)

biotene and various design elements are trademarks of the GlaxoSmithKline group of companies.

www.biotene.com

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2013 GlaxoSmithKline

102875XA

Biotene Fresh Mint Original 4.3 oz carton

Principal Display Panel

NDC 0135-0558-01

biotene®

ESSENTIAL FLUORIDE TOOTH PROTECTION

DRY MOUTH

FLUORIDE TOOTHPASTE

Gentle Formula

Designed to Not Irritate a Dry Mouth

NEW Improved pH Balance

GENTLE MINT

NET WT 4.3 OZ (121.9g)

#1 RECOMMENDED DRY MOUTH BRAND

Helps Maintain Oral Environment

Helps Prevent Cavities
Designed to Not Irritate a Dry Mouth
SLS Free
Mild Flavor
Helps Freshen Bad Breath

#1 Dentist & Hygienist Recommended Brand for Dry Mouth

If you suffer from dry mouth you may be experiencing some of these problems.

Constant dry feeling
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.

With brushing biotene® toothpaste helps maintain a healthy oral environment and provides essential fluoride tooth protection for dry mouth sufferers or for people who need mild toothpaste.

ALWAYS FOLLOW THE LABEL

This product contains no Sodium Lauryl Sulfate (SLS)

biotene and various design elements are trademarks of the GlaxoSmithKline group of companies.

www.biotene.com

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2013 GlaxoSmithKline

102874XA

Biotene Gentle Mint Original 4.3 oz carton

Principal Display Panel

NDC 0135-0559-01

biotene®

ESSENTIAL FLUORIDE TOOTH PROTECTION

PBF DRY MOUTH

FLUORIDE TOOTHPASTE

Gentle Formula

Designed to Not Irritate a Dry Mouth

NEW Improved pH Balance

PLAQUE-BIOFILM LOOSENING FORMULA

NET WT 4.3 OZ (121.9g)

#1 RECOMMENDED DRY MOUTH BRAND

Helps Maintain Oral Environment

Plague-BioFilm Loosening
Helps Freshen Breath
SLS Free
Helps Fight Cavities
Designed to Not Irritate a Dry Mouth

#1 Dentist & Hygienist Recommended Brand for Dry Mouth

Specially formulated toothpaste technology that helps loosen the BioFilm. Likebiotene®Original toothpaste, biotene®PBF toothpaste provides essential fluoride tooth protection to help maintain a healthy oral environment with brushing.

Biotene®PBF toothpaste helps loosen Plaque BioFilm with regular brushing.

Over 400 commonly used drugs may reduce your saliva flow.

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

ALWAYS FOLLOW THE LABEL

This product contains no Sodium Lauryl Sulfate (SLS)

biotene and various design elements are trademarks of the GlaxoSmithKline group of companies.

www.biotene.com

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2013 GlaxoSmithKline

102869XA

Biotene PBF 4.3 oz carton
BIOTENE  FRESH MINT ORIGINAL
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0557
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
COCAMIDOPROPYL BETAINE 
XANTHAN GUM 
SACCHARIN SODIUM 
SUCRALOSE 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Fresh Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0557-011 in 1 CARTON
1121.9 g in 1 TUBE
2NDC:0135-0557-021 in 1 CARTON
219.8 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/15/2013
BIOTENE  GENTLE MINT
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0558
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
COCAMIDOPROPYL BETAINE 
XANTHAN GUM 
SACCHARIN SODIUM 
SUCRALOSE 
SODIUM HYDROXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (Gentle Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0558-011 in 1 CARTON
1121.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/15/2013
BIOTENE  PBF
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0135-0559
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
HYDRATED SILICA 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
COCAMIDOPROPYL BETAINE 
XANTHAN GUM 
SACCHARIN SODIUM 
SUCRALOSE 
SODIUM HYDROXIDE 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0559-011 in 1 CARTON
1121.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/15/2013
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 9/2013
Document Id: 0a64b2eb-f524-4104-9002-817beef87e9b
Set id: 1101c17f-c848-4cd5-a7cd-679b59dbe1bf
Version: 3
Effective Time: 20130920
 
GlaxoSmithKline Consumer Healthcare LP