BIOTENE description, usages, side effects, indications, overdosage, supplying and lots more!

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BIOTENE

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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 Type Human otc drug label 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 1.4 mg

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 127.6 in 1 TUBE
2 NDC:0135-0490-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-04-18


BIOTENE

sodium monofluorophosphate PASTE

Product Information

Product Type Human otc drug label 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 1.4 mg

Inactive Ingredients

Ingredient Name Strength
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

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 127.6 in 1 TUBE
2 21.3 in 1 TUBE
3 NDC:0135-0487-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-04-18


BIOTENE

sodium monofluorophosphate GEL

Product Information

Product Type Human otc drug label 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 1.4 mg

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)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 127.6 in 1 TUBE
2 NDC:0135-0488-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2011-04-18


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Be sure to consult your doctor before taking any medication!
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