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

BIOTENE by

Drug Labeling and Warnings

BIOTENE by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (Fresh Mint and Gentle Mint)

If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients.

Keep out of reach of children 12 years of age and under. (PBF)

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®

FLUORIDE TOOTHPASTE

GENTLE FORMULA

SPECIALLY FORMULATED TO NOT IRRITATE

FRESH MINT ORIGINAL

NET WT 4.3 OZ (121.9g)

FROM THE MAKERS OF BIOTENE

#1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS

HELPS MAINTAIN ORAL ENVIRONMENT

• HELPS FRESHEN BAD BREATH
• SLS FREE
• BALANCED PH
• GENTLE FORMULA
• ESSENTIAL FLUORIDE TOOTH PROTECTION

Also look for other biotene® products including biotene® Oral Rinses, biotene® oralbalance Gel, and biotene® Mouth Spray.

ALWAYS FOLLOW THE LABEL

This product contains no Sodium Lauryl Sulfate (SLS)

Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies.

www.biotene.com

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2014 GSK

102875XC

Principal Display Panel

NDC: 0135-0558-01

biotene®

FLUORIDE TOOTHPASTE

GENTLE FORMULA

SPECIALLY FORMULATED TO NOT IRRITATE

GENTLE MINT

NET WT 4.3 OZ (121.9g)

FROM THE MAKERS OF BIOTENE

#1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS

HELPS MAINTAIN ORAL ENVIRONMENT

• HELPS FRESHEN BAD BREATH
• SLS FREE
• BALANCED PH
• GENTLE FORMULA
• ESSENTIAL FLUORIDE TOOTH PROTECTION

Also look for other biotene® products including biotene® Oral Rinses, biotene® oralbalance Gel, and biotene® Mouth Spray.

ALWAYS FOLLOW THE LABEL

This product contains no Sodium Lauryl Sulfate (SLS)

Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2014 GSK

102874XC

Principal Display Panel

NDC: 0135-0559-01

biotene®

DRY MOUTH

PBF® FLUORIDE TOOTHPASTE

GENTLE FORMULA

DESIGNED TO NOT IRRITATE A DRY MOUTH

PLAQUE-BIOFILM LOOSENING FORMULA

NET WT 4.3 OZ (121.9g)

#1 Dentist & Hygienist Recommended Brand for Dry Mouth

HELPS MAINTAIN ORAL ENVIRONMENT

• HELPS FRESHEN BAD BREATH
• SLS FREE
• BALANCED PH
• GENTLE FORMULA
• ESSENTIAL FLUORIDE TOOTH PROTECTION

Also look for other biotene®products including biotene®Oral Rinses, biotene® oralbalance Gel, biotene® Mouth Spray and biotene®Gum.

ALWAYS FOLLOW THE LABEL

This product contains no Sodium Lauryl Sulfate (SLS)

biotene, biotene PBF, oralbalance and graphic elements are trademarks of the GSK group of companies.

www.biotene.com

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

©2014 GSK

102869XB

INGREDIENTS AND APPEARANCE

BIOTENE  FRESH MINT ORIGINAL
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0557
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT (Fresh Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0557-01	1 in 1 CARTON	07/15/2013
1		121.9 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0557-02	1 in 1 CARTON	07/15/2013
2		19.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/15/2013

BIOTENE  GENTLE MINT
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0558
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT (Gentle Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0558-01	1 in 1 CARTON	07/15/2013
1		121.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/15/2013

BIOTENE  PBF
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0559
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0559-01	1 in 1 CARTON	07/15/2013	07/31/2016
1		121.9 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/15/2013	07/31/2016

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)