Sensodyne Paste
FDA Label NDC 0135-0593

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 0135-0593). 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, 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 Ingredient

Potassium nitrate 5%**

Sodium fluoride 0.25% (0.16% w/v fluoride ion)

**maximum FDA sensitivity active ingredient

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)

Inactive Ingredients

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, sodium hydroxide, cocamidopropyl betaine, sodium saccharin, blue 1

Questions Or Comments?

Call toll-free 1-866-844-2797

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NDC 0135-0593-01

SENSODYNE®

Deep Clean

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MAXIMUM STRENGTH** WITH FLORIDE

24/7 SENSITIVITY PROTECTION*

#1 Dentist Recommended Brand†

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

Advanced Cleaning & Lasting Freshness

NET WT4.0 OZ (113 g)

#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.

  • Long lasting sensitivity protection*
  • Foam boost technology
  • Provides all the benefits of a regular fluoride toothpaste*

    • *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.

    BEFORE

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

    24 hr PROTECTION*

    AFTER

    Sensodyne Deep Clean works inside the tooth to help calm the nerves for 24hr sensitivity protection.*

    GSK Consumer Healthcare

    Warren, NJ 07059

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

    1-866-844-2797

    105470XB

* Please review the disclaimer below.