BIOTENE

Dosage form: paste
Ingredients: SODIUM MONOFLUOROPHOSPHATE 1.4mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0490

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.

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®

withXylitol®

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

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

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 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0490
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0490-011 TUBE in 1 CARTON
1127.6 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/18/2011
BIOTENE  FRESH MINT ORIGINAL
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0487
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL 
GLYCERIN 
CALCIUM PYROPHOSPHATE 
WATER 
HYDRATED SILICA 
XYLITOL 
SILICON DIOXIDE 
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) 
CETETH-20 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM BENZOATE 
LACTOPEROXIDASE BOVINE 
POTASSIUM THIOCYANATE 
GLUCOSE OXIDASE 
LYSOZYME, CHICKEN EGG WHITE 
TALACTOFERRIN ALFA 
CALCIUM LACTATE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Fresh Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0487-011 TUBE in 1 CARTON
1127.6 g in 1 TUBE
2NDC:0135-0487-021 TUBE in 1 CARTON
221.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/18/2011
BIOTENE  GENTLE MINT
sodium monofluorophosphate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0488
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (blue green) Score    
ShapeSize
FlavorMINT (Gentle mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0488-011 TUBE in 1 CARTON
1127.6 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/18/2011
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 08/2014
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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