Sensodyne Paste
FDA Label NDC 0135-0643

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 0135-0643). 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 0.24% (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, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, flavor, cocamidopropyl betaine, sodium methyl cocoyl taurate, titanium dioxide, xanthan gum, sodium hydroxide, sodium saccharin

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. *with twice daily brushing.

Exposed Dentin

24/7

Sensitivity Protection*

+ Strong & Healthy Teeth

Use Sensodyne Extra Whitening

Cool Mint twice dally:

• Long lasting sensitivity protection* everyday

• Contains fluoride to protect against cavities

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

©2022 GSK group of companies or its licensor.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Principal Display Panel

SENSODYNE

#1 DENTIST RECOMMENDED BRAND

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

Extra Whitening

Cool Mint

NET WT 4.0 OZ (113 g)

62000000079742 Front Carton

Sensodyne Extra Whitening Cool Mint 4.0 Oz(113 G) (Image 01)

Sensodyne Extra Whitening Cool Mint 4.0 Oz(113 G) (Image 01)

* Please review the disclaimer below.