Biotene Paste
FDA Label NDC 0135-0557

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Biotene (NDC 0135-0557). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, keep out of reach of children 12 years of age and under (fresh mint and gentle mint), keep out of reach of children 12 years of age and under. (pbf), directions, other information, inactive ingredients (fresh mint original), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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