Sensodyne Paste
FDA Label NDC 0135-5028

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 0135-5028). 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.

Label Section Quick Index

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: Consult a dentist or doctor.

Other Information

  • do not store above 25°C (77°F)

Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, charcoal powder, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, sodium hydroxide, sucralose

Questions Or Comments?

1-866-844-2797

Additional Information

ALWAYS FOLLOW THE LABEL

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.

The active ingredient in Sensodyne is clinically proven to deliver 24/7 sensitivity protection*

Also contains:

Coconut derived charcoal to help restore teeth to their natural whiteness

Use Sensodyne Natural White twice daily:

  • Long-lasting sensitivity protection*
  • Contains fluoride to protect against cavities
  • Helps remove stains for whiter teeth
  • Freshens breath

    • *with twice daily brushing

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

    ©2021 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

Principal Display Panel

NDC 0135-5028-01

new

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

Natural White

with coconut derived charcoal

NET WT 4.0 OZ (113 g)

1001361 Carton Front

Sensodyne Natural White 4.0oz (113g) Carton (Image 01)

Sensodyne Natural White 4.0oz (113g) Carton (Image 01)

* Please review the disclaimer below.