Sensodyne Paste
FDA Label NDC 0135-0479

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 0135-0479). 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, purposes, uses, stop use and ask a dentist if, keep out of reach of children., directions, other information, inactive ingredients (advanced whitening), 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% (0.16% 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 30° C (86 °F)

Inactive Ingredients (Advanced Whitening)

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

Questions Or Comments?

1-866-844-2797

Principal Display Panel

NDC 0135-0479-01

SENSODYNE Advanced Whitening

Maximum Strength** with Fluoride

**maximum FDA sensitivity active ingredient

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 6.5 OZ (184 g)

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

#1 Dentist Recommended Brand for Sensitive Teeth

Dentists have been recommending Sensodyne for many years. Sensodyne Advanced Whitening is a fluoride toothpaste. It can be used everyday and provides daily care for sensitive teeth.

Sensodyne is specially formulated to relieve tooth sensitivity. When enamel is worn away or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity pain, for example, with hot and cold food and drinks.

24/7 SENSITIVITY PROTECTION*

24 hr protection*

BEFORE: Sensitivity starts with exposed dentin. Sensitive teeth need special care.

AFTER: Sensodyne Advanced Whitening works inside the tooth to help calm the nerves for 24 hr sensitivity protection.*

*with twice daily brushing

ADVANCED WHITENING

Use Sensodyne Advanced Whitening twice daily:

  • Long lasting sensitivity protection
  • Helps bring back the natural whiteness of your teeth
  • Helps to remove stains for whiter teeth
  • Provides the benefits of a regular toothpaste

    • This product contains no sugar.

    ALWAYS FOLLOW THE LABEL

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

    ©2020 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    62000000050449

    62000000050449_sensodyne_advanced_whitening (Image 01)

    62000000050449_sensodyne_advanced_whitening (Image 01)

* Please review the disclaimer below.