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 LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/14

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.

    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®

    DRY MOUTH

    FLUORIDE TOOTHPASTE

    Gentle Formula

    DESIGNED TO NOT IRRITATE A DRY MOUTH

    FRESH MINT ORIGINAL

    NET WT 4.3 OZ (121.9g)

    #1 DENTIST & HYGIENTIST 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 Sprays and biotene® Gum

    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

    102875XB

    Biotene Fresh Mint Original 4.3 oz (121.9) carton
    Close
  • Principal Display Panel

    NDC 0135-0558-01

    biotene®

    DRY MOUTH

    FLUORIDE TOOTHPASTE

    Gentle Formula

    DESIGNED TO NOT IRRITATE A DRY MOUTH

    GENTLE MINT

    NET WT 4.3 OZ (121.9g)

    #1 DENTIST & HYGIENTIST 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 Sprays and biotene® Gum

    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

    102874XB

    Biotene Gentle Mint Original 4.3 oz (121.9g) carton
    Close
  • Principal Display Panel

    NDC 0135-0559-01

    biotene®

    ESSENTIAL FLUORIDE TOOTH PROTECTION

    PBF DRY MOUTH

    FLUORIDE TOOTHPASTE

    Gentle Formula

    Designed to Not Irritate a Dry Mouth

    NEW Improved pH Balance

    PLAQUE-BIOFILM LOOSENING FORMULA

    NET WT 4.3 OZ (121.9g)

    #1 RECOMMENDED DRY MOUTH BRAND

    Helps Maintain Oral Environment

    Plague-BioFilm Loosening
    Helps Freshen Breath
    SLS Free
    Helps Fight Cavities
    Designed to Not Irritate a Dry Mouth

    #1 Dentist & Hygienist Recommended Brand for Dry Mouth

    Specially formulated toothpaste technology that helps loosen the BioFilm. Likebiotene®Original toothpaste, biotene®PBF toothpaste provides essential fluoride tooth protection to help maintain a healthy oral environment with brushing.

    Biotene®PBF toothpaste helps loosen Plaque BioFilm with regular brushing.

    Over 400 commonly used drugs may reduce your saliva flow.

    BioFilm is the bacterial film on your teeth often described as plaque. With a dry mouth, saliva’s natural ability to cleanse and control BioFilm is reduced.

    ALWAYS FOLLOW THE LABEL

    This product contains no Sodium Lauryl Sulfate (SLS)

    biotene and various design elements are trademarks of the GlaxoSmithKline group of companies.

    www.biotene.com

    Distributed by:

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Township, PA 15108

    ©2013 GlaxoSmithKline

    102869XA

    Biotene PBF 4.3 oz carton
    Close
  • INGREDIENTS AND APPEARANCE
    BIOTENE  FRESH MINT ORIGINAL
    sodium fluoride paste
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0557
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    HYDRATED SILICA  
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    COCAMIDOPROPYL BETAINE  
    XANTHAN GUM  
    SACCHARIN SODIUM  
    SUCRALOSE  
    TITANIUM DIOXIDE  
    SODIUM HYDROXIDE  
    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
    1 121.9 g in 1 TUBE; Combination Product Type = C112160
    2 NDC:0135-0557-02 1 in 1 CARTON
    2 19.8 g in 1 TUBE; Combination Product Type = C112160
    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 LABEL Item Code (Source) NDC:0135-0558
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    HYDRATED SILICA  
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    COCAMIDOPROPYL BETAINE  
    XANTHAN GUM  
    SACCHARIN SODIUM  
    SUCRALOSE  
    SODIUM HYDROXIDE  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    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
    1 121.9 g in 1 TUBE; Combination Product Type = C112160
    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 LABEL Item Code (Source) NDC:0135-0559
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    HYDRATED SILICA  
    GLYCERIN  
    POLYETHYLENE GLYCOL 400  
    COCAMIDOPROPYL BETAINE  
    XANTHAN GUM  
    SACCHARIN SODIUM  
    SUCRALOSE  
    SODIUM HYDROXIDE  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    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
    1 121.9 g in 1 TUBE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 07/15/2013
    Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)
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