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

  • NDC Code(s): 0135-0557-01, 0135-0557-02, 0135-0558-01, 0135-0559-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated December 21, 2016

If you are a consumer or patient please visit this version.

  • Active ingredient

    Sodium Fluoride (0.15% w/v fluoride ion)

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  • Purpose

    Anticavity

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  • Use

    aids in the prevention of dental cavities

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  • 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.

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  • 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.

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  • Other information

    store below 25°C (77F°)

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  • Inactive ingredients (Fresh Mint Original)

    Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide

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  • 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

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  • 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

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  • Questions or comments?

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

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  • 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
    Close
  • 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
    Close
  • 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
    Close
  • 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)
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