Sensodyne Pronamel Paste
FDA Label NDC 0135-0486

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 Sensodyne Pronamel (NDC 0135-0486). 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, uses, warnings, when using this product,, stop use and ask a dentist if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

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.

Warnings

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When Using This Product,

if irritation occurs discontinue use.

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 (Clean Mint, Extra Fresh)

store below 25°C (77°F)

Inactive Ingredients (Clean Mint)

water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Inactive Ingredients (Extra Fresh)

water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Questions Or Comments?

Call toll-free 1-866-844-2797

Principal Display Panel

New

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

CLEAN MINT

ACTIVELY REPAIRS WEAKENED ENAMEL*

NET WT 3.4 OZ (96.4 g)

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

*Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

LOCKS IN MINERALS

FOR STRONG HEALTHY TEETH

Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

  • Actively repair acid-weakened enamel
  • Lock in minerals to protect against the effects of acid wear
  • Protect against cavities

    • Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

    ALWAYS FOLLOW THE LABEL

    Trademarks owned or licensed by GSK.

    ©2018 GSK or licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    106406XA

    NDC 0135-0486-01

    New

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    EXTRA FRESH

    ACTIVELY REPAIRS WEAKENED ENAMEL*

    NET WT 3.4 OZ (96.4 g)

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    *Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

    PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

    LOCKS IN MINERALS

    FOR STRONG HEALTHY TEETH

    Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

    With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

    • Actively repair acid-weakened enamel
    • Lock in minerals to protect against the effects of acid wear
    • Protect against cavities

      • Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

      ALWAYS FOLLOW THE LABEL

      Trademarks owned or licensed by GSK.

      ©2018 GSK or licensor.

      Distributed by:

      GSK Consumer Healthcare

      Warren, NJ 07059

      106407XA

* Please review the disclaimer below.