Sensodyne Paste
FDA Label NDC 0135-5029

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 (NDC 0135-5029). 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, purposes, uses, stop use and ask a dentist if, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Potassium nitrate 5%

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

Purposes

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

  • do not store above 25°C (77°F)

Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, flavor, silica, xanthan gum, sodium methyl cocoyl taurate, cocamidopropyl betaine, titanium dioxide, sodium hydroxide, sodium saccharin, sucralose

Questions Or Comments?

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Additional Information

SENSODYNE

Advanced Whitening PLUS

What are sensitive teeth?

Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or

drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity,

for example, with cold and hot food and drinks.

What does Sensodyne do?

Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness.

helps remove stains for a whiter smile, while calming the nerves deep inside the tooth for 24 hour sensitivity relief*that helps keep the pain from coming back

24/7 Sensitivity Protection*

+ Triple Action Whitening

Use Sensodyne Advanced Whitening PLUS twice daily:

• Long lasting sensitivity protection*

+ Triple action whitening

  • Removes stains
  • Polishes enamel
  • Prevents future stains
  • • Contains fluoride to protect against cavities

    * with twice daily brushing

    ^ removes stains, polishes enamel,

    and prevents future stains

    † lower abrasivity vs Sensodyne

    Advanced Whitening

    CARTON RECYCLE

    TUBE RECYCLE

    CAP CHECK LOCALLY

    †Recycling facilities for the cap may not exist in your area

    Save Water

    Turn off tap while brushing

    Recyclable Packaging

    Recyclable Carton

    Recyclable Tube & Cap

    Distributed by:

    Haleon

    Warren, NJ 07059

    Trademarks owned or licensed by Haleon.

    ©2024 Haleon or licensor.

    Pat. Info www.productpats.com

    62000000209613

Principal Display Panel

4 Pack HALEON

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

Advanced Whitening PLUS

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

24/7 SENSITIVITY PROTECTION + TRIPLE ACTION WHITENING

4 TUBES OF 6.5 OZ (184 g) EACH - TOTAL NET WT 26 OZ (736 g)

* Please review the disclaimer below.