Sensodyne Paste, Dentifrice
FDA Label NDC 0135-5913

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 0135-5913). 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, 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 Ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity

Antihypersensitivity

Uses

  • aids in the prevention of dental cavities.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

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

  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this product is specifically formulated to help prevent staining.
  • do not store above 30°C (86°F)

Inactive Ingredients

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, perlite, flavor, sodium lauryl sulfate, silica, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, blue 1

Questions Or Comments?

1-866-844-2797

Additional Information (Fresh Clean)

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINCAL REPAIR

CLINICALLY PROVEN

SENSITIVITY RELIEF

ACTIVATES

Formula activates as soon as you begin to brush your teeth*

REPAIRS

Forms a protective layer inside and over exposed sensitive areas** to block the nerves from sensitivity triggers

PROTECTS

Clinically proven to provide long-lasting sensitivity relief and help prevent the pain from coming back**

SUPERIOR CLEANING ACTION

through stain removal***

Gentle on sensitive teeth

*for substantial sensitivity relief in 3 days

**with continued twice daily brushing

***vs Sensodyne Repair & Protect Deep Repair

Additional Information (Whiten & Shine)

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINICAL REPAIR

CLINCALLY PROVEN

SENSITIVITY RELIEF

ACTIVATES

Formula activates as soon as you begin to brush your teeth*

REPAIRS

Forms a protective layer inside and over exposed sensitive areas** to block the nerves from sensitivity triggers

PROTECTS

Clinically proven to provide long-lasting sensitivity relief and help prevent the pain from coming back**

SUPERIOR WHITENING ACTION

through stain removal***

Gentle on sensitive teeth

*for substantial sensitivity relief in 3 days

**with continued twice daily brushing

***vs Sensodyne Repair & Protect Deep Repair

Principal Display Panel- Whiten & Shine

NEW

HALEON

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

STARTS TO REPAIR SENSITIVE AREAS OF THE TEETH AFTER 60 SEC*

CLINICAL REPAIR

REPARATIVE ACTION PROVEN TO RELIEVE SENSITIVITY

WHITEN & SHINE

NET WT 3.4 OZ (96.4 g)

Principal Display Panel- Fresh Clean

NEW

HALEON

TOOTHPASTE FOR SENSTIVE TEETH AND CAVITY PREVENTION

SENSODYNE

STARTS TO REPAIR SENSTIVE AREAS OF TEETH AFTER 60 SEC*

CLINICAL REPAIR

REPARATIVE ACTION PROVEN TO RELIEVE SENSITIVITY

FRESH CLEAN

NET WT 3.4 OZ (96.4 g)

* Please review the disclaimer below.