Sensodyne Pronamel Paste
FDA Label NDC 0135-0603

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 0135-0603). 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, when using this product,, stop use and ask a dentist if, keep out of reach of children., directions, other information, 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.

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

Consult a dentist or doctor.

Other Information

store below 25°C (77°F)

Inactive Ingredients

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

Questions Or Comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0602-01

SENSODYNE

PRONAMEL

STRONG & Bright

ENAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

STRONG ENAMEL

WHITER TEETH*

MINT

No. 1 DENTIST RECOMMENDED BRAND

FOR STRENGTHENING AND PROTECTING ENAMEL

*vs. ProNamel Daily Protection

NET WT 3.0 OZ (85 g)

Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

Sensodyne ProNamel STRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

*vs. ProNamel Daily Protection

With twice daily brushing, the dual action formulation:

  • Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
  • Polishes away stains for WHITER BRIGHTER TEETH.

    • FRESHENS breath and fights CAVITIES

    GSK Consumer Healthcare

    Warren, NJ 07059

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

    ©2017 GSK group of companies or its licensor

    ALWAYS FOLLOW THE LABEL

    105491XC

    105491xc_pronamel Strong & Bright_3.0 Oz.jpg (Image 01)

    105491xc_pronamel Strong & Bright_3.0 Oz.jpg (Image 01)

    NDC 0135-0603-01

    SENSODYNE

    PRONAMEL

    STRONG & Bright

    ENAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    STRONG ENAMEL

    WHITER TEETH*

    EXTRA FRESH

    No. 1 DENTIST RECOMMENDED BRAND

    FOR STRENGTHENING AND PROTECTING ENAMEL

    *vs. ProNamel Daily Protection

    NET WT 3.0 OZ (85 g)

    Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

    Sensodyne ProNamelSTRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

    *vs. ProNamel Daily Protection

    With twice daily brushing, the dual action formulation:

    • Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
    • Polishes away stains for WHITER BRIGHTER TEETH.

      • FRESHENS breath and fights CAVITIES

      GSK Consumer Healthcare

      Warren, NJ 07059

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

      ©2017 GSK group of companies or its licensor.

      ALWAYS FOLLOW THE LABEL

      105488XC

* Please review the disclaimer below.