Sensodyne Pronamel Paste
FDA Label NDC 0135-0484

13 label sections · Submitted to the FDA by Haleon Us Holdings Llc · 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 Sensodyne Pronamel (NDC 0135-0484). 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 ingredients, purpose, uses, stop use and ask a dentist if, keep out of reach of children., directions, other information (gentle whitening, daily protection, fresh breath, multi-action), inactive ingredients (gentle whitening), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • aids in the prevention of dental cavities.

Stop Use And Ask A Dentist If

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.

Keep Out Of Reach Of Children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and older:
    • apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    • children under 12 years of age:Consult a dentist or doctor.

Other Information (Gentle Whitening, Daily Protection, Fresh Breath, Multi-Action)

  • do not store above 30°C (86°F)

Inactive Ingredients (Gentle Whitening)

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Inactive Ingredients (Daily Protection)

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

Inactive Ingredients (Fresh Breath)

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

Inactive Ingredients (Multi-Action)

water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, mica, titanium dioxide, sodium hydroxide

Questions Or Comments?

1-866-844-2797

Principal Display Panel

NDC 0135-0484-01

SENSODYNE

PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Alpine Breeze

GENTLE WHITENING

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

NET WT 4.0 OZ (113g)

ALWAYS FOLLOW THE LABEL

SENSODYNE PRONAMEL

Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

ACID ATTACKS ENAMEL

WEAKENING THE ENAMEL STRUCTURE

PRONAMEL REBUILDS & RESTORES ENAMEL

FOR STRONG HEALTHY TEETH

Healthy white teeth start with strong enamel.

Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

With twice-daily brushing,
Pronamel helps to:

  • Rebuild enamel strength for strong, healthy teeth
  • Protect against the effects of dietary acids
  • Relieve sensitive teeth
  • Freshen breath
  • Protect against cavities

    • Recycle Carton, Tube and Cap†

    Save Water Turn off tap while brushing

    †Recycling facilities for this product may not exist in your area

    Distributed by:

    GSKConsumer Healthcare

    Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2021 GSK group of companies or its licensor.

    62000000068970 Front Carton

    NDC 0135-0460-01

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    Mint Essence

    DAILY PROTECTION

    Specialist Enamel Protection

    Rebuilds, Restores, Refreshes

    NET WT 4.0 OZ (113 g)

    ALWAYS FOLLOW THE LABEL

    SENSODYNE PRONAMEL

    Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

    Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

    ACID ATTACKS ENAMEL

    WEAKENING THE ENAMEL STRUCTURE

    PRONAMEL REBUILDS & RESTORES ENAMEL

    FOR STRONG HEALTHY TEETH

    Healthy white teeth start with strong enamel.

    Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

    With twice-daily brushing,
    Pronamel helps to:

    • Rebuild enamel strength for strong, healthy teeth
    • Protect against the effects of dietary acids
    • Relieve sensitive teeth
    • Freshen breath
    • Protect against cavities

      • Recycle Carton, Tube and Cap†

      Save Water Turn off tap while brushing

      †Recycling facilities for this product may not exist in your area

      Distributed by:

      GSKConsumer Healthcare

      Warren, NJ 07059

      Trademarks are owned by or licensed to the GSK group of companies.

      ©2021 GSK group of companies or its licensor.

      62000000068992 Front Carton

      NDC 0135-0520-01

      SENSODYNE

      PRONAMEL

      TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

      Fresh Wave

      FRESH BREATH

      Specialist Enamel Protection

      Rebuilds, Restores, Refreshes

      NET WT 4.0 OZ (113 g)

      ALWAYS FOLLOW THE LABEL

      SENSODYNE PRONAMEL

      Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

      Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

      ACID ATTACKS ENAMEL

      WEAKENING THE ENAMEL STRUCTURE

      PRONAMEL REBUILDS & RESTORES ENAMEL

      FOR STRONG HEALTHY TEETH

      Healthy white teeth start with strong enamel.

      Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

      With twice-daily brushing,
      Pronamel helps to:

      • Rebuild enamel strength for strong, healthy teeth
      • Protect against the effects of dietary acids
      • Relieve sensitive teeth
      • Freshen breath
      • Protect against cavities

        • Recycle Carton, Tube and Cap†

        Save Water Turn off tap while brushing

        †Recycling facilities for this product may not exist in your area

        Distributed by:

        GSK Consumer Healthcare

        Warren, NJ 07059

        Trademarks are owned by or licensed to the GSK group of companies.

        ©2021 GSK group of companies or its licensor.

        62000000068910 Front Carton

        NDC 0135-0568-04

        SENSODYNE

        PRONAMEL

        TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

        Cleansing Mint

        MULTI-ACTION

        Specialist Enamel Protection

        Rebuilds, Restores, Refreshes

        NET WT 4.0 OZ (113 g)

        ALWAYS FOLLOW THE LABEL

        SENSODYNE PRONAMEL

        Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

        Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

        ACID ATTACKS ENAMEL

        WEAKENING THE ENAMEL STRUCTURE

        PRONAMEL REBUILDS & RESTORES ENAMEL

        FOR STRONG HEALTHY TEETH

        Healthy white teeth start with strong enamel.

        Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

        With twice-daily brushing,
        Pronamel helps to:

        • Rebuild enamel strength for strong, healthy teeth
        • Protect against the effects of dietary acids
        • Relieve sensitive teeth
        • Freshen breath
        • Protect against cavities

          • Recycle Carton, Tube and Cap†

          Save Water Turn off tap while brushing

          Distributed by:

          GSKConsumer Healthcare

          Warren, NJ 07059

          Trademarks are owned by or licensed to the GSK group of companies.

          ©2021 GSK group of companies or its licensor.

          62000000069352 Front Carton

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