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  5. Label Information: Biotene Fresh Mint Original

FDA Label for Biotene Fresh Mint Original

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. KEEP OUT OF REACH OF CHILDREN 12 YEARS OF AGE AND UNDER (FRESH MINT AND GENTLE MINT)
    5. KEEP OUT OF REACH OF CHILDREN 12 YEARS OF AGE AND UNDER. (PBF)
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS (FRESH MINT ORIGINAL)
    9. INACTIVE INGREDIENTS (GENTLE MINT)
    10. INACTIVE INGREDIENTS (PBF)
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL

Biotene Fresh Mint Original Product Label

The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Sodium Fluoride (0.15% w/v fluoride ion)


Purpose



Anticavity


Use



aids in the prevention of dental cavities


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

    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

      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


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