BIOTENE FRESH MINT ORIGINAL- sodium fluoride paste 
BIOTENE GENTLE MINT- sodium fluoride paste 
BIOTENE PBF- sodium fluoride paste 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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 (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

Biotene Fresh Mint Original 4.3 oz (121.9) carton

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

Biotene Gentle Mint Original 4.3 oz (121.9g) carton

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

Biotene PBF 4.3 oz carton
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)

Revised: 12/2016
Document Id: 9495b36d-16aa-4e65-bcda-bbc027146c4c
Set id: 1101c17f-c848-4cd5-a7cd-679b59dbe1bf
Version: 6
Effective Time: 20161221
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC