Sensodyne Paste
FDA Label NDC 0135-5468

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 0135-5468). 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 thorough 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, sodium lauryl sulfate, flavor, alumina, titanium dioxide, xanthan gum, cocamidopropyl betain, sodium hydroxide, carrageenan, sodium saccharin

Questions Or Comments?

1-866-844-2797

Generic Section

ALWAYS FOLLOW THE LABEL

SENSODYNE

WHITE

CLINICALLY PROVEN WHITENING DESIGNED FOR SENSITIVE TEETH

WHITENING

Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains

SENSITIVITY PROTECTION

Clinically proven ingredients to protect against sensitivity and strengthen enamel

7X BETTER CLEANING^

Through stain removal

ENAMEL SAFE

* As shown in an 8 week study.

** With twice daily brushing.

^ After 8 weeks twice daily brushing as compared to a non-whitening toothpaste.

Principal Display Panel

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

2 SHADES WHITER TEETH*

+ 24/7 SENSITIVITY PROTECTION**

CLINICAL WHITE

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

INTENSIVE CLEAN

NET WT 3.4 OZ (96.4 g)

* Please review the disclaimer below.