Sensodyne
FDA Label NDC 0135-0551

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 0135-0551). 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, purpose, uses, when using this product,, stop use and ask a dentist if, keep out of reach of children., directions, other information, 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)

Purpose

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.

When Using This Product,

if irritation occurs discontinue use.

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

  • store below 30°C (86°F)

Inactiveingredients

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

Questions Or Comments?

call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0550-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Full Protection + WHITENING

24/7 SENSITIVITY PROTECTION*

#1 Dentist Recommended Brand*

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

NET WT 4.0 OZ (113 g)

USE SENSODYNE® toothpaste whenever you normally brush:

  • ✓Clinically proven ingredient reduces painful sensitivity
  • ✓Provides sensitivity relief in as little as two weeks
  • ✓Helps maintain healthy gums with regular brushing
  • ✓Whitens teeth by removing surface stains
  • ✓Leaves your mouth feeling clean and fresh
  • ✓Contains fluoride for cavity protection

    • *#1 Dentist Recommended Brand for Sensitive Teeth†

    †Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a “shield of protection” against painful sensitivity. And, since Sensodyne ® toothpaste has fluoride, it helps protect against cavities too.

    *with twice daily brushing

    **maximum FDA sensitivity active ingredient

    This product contains no sugar.

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

    ©2016 GSK group of companies or its licensor. All rights reserved.

    105784XA

    NDC 0135-0551-04

    SENSODYNE®

    MAXIMUM STRENGTH** WITH FLUORIDE

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    Tartar Control + WHITENING

    #1 Dentist Recommended Brand

    9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

    24/7 SENSITIVTY PROTECTION*

    NET WT 4.0 OZ (113 g)

    USE SENSODYNE® toothpaste whenever you normally brush:

    • ✓Clinically proven ingredient reduces painful sensitivity
    • ✓Provides sensitivity relief in as little as two weeks
    • ✓Helps remove tartar build-up above the gum line with regular brushing
    • ✓Helps whiten teeth by removing surface stains
    • ✓Leaves your mouth feeling clean and fresh
    • ✓Contains fluoride for cavity protection

      • #1 Dentist Recommended Brand for Sensitive Teeth†

      †Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a “shield of protection” against painful sensitivity. And, since Sensodyne ® toothpaste has fluoride, it helps protect against cavities too.

      *with twice daily brushing

      **maximum FDA sensitivity active ingredient

      This product contains no sugar.

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

      ©2016 GSK group of companies or its licensor. All rights reserved.

      105748XA

* Please review the disclaimer below.