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

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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

Children 12 years and underask 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

Questions or comments?

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

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

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, oralbalanceand 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

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, oralbalanceand 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
BIOTENE  FRESH MINT ORIGINAL
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0557
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorMINT (Fresh Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0557-011 in 1 CARTON07/15/2013
1121.9 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0557-021 in 1 CARTON07/15/2013
219.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02207/15/2013
BIOTENE  GENTLE MINT
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0558
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScore    
ShapeSize
FlavorMINT (Gentle Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0558-011 in 1 CARTON07/15/2013
1121.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02207/15/2013
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 11/2023
Document Id: 0a3dc8fe-4218-85fa-e063-6294a90ad359
Set id: 1101c17f-c848-4cd5-a7cd-679b59dbe1bf
Version: 9
Effective Time: 20231115
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC