Active Ingredient
Stannous fluoride 0.454% (0.15% w/v fluoride ion)
Sensodyne Paste
FDA Label NDC 0135-0547
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 0135-0547). 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, 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
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
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
- products containing stannous fluoride may product 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
- store below 30°C (86°F)
Inactive Ingredients (Regular)
glycerin, PEG-8, hydrated silica, pentasodium triphosphate, sodium lauryl sulfate, flavor, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin
Inactive Ingredients (Extra Fresh)
glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine
Inactive Ingredients (Whitening)
glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin
Questions Or Comments?
call toll-free 1-866-844-2797
Principal Display Panel
NDC 0135-0548-02
SENSODYNE®
WITH FLUORIDE
DAILY REPAIR* TOOTHPASTE
TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION
NET WT 3.4 oz (96.4g)
#1 Dentist Recommended Brand
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
REPAIR & PROTECT
Proven relief and protection from sensitivity pain*
Daily protection for sensitive teeth*
Contains fluoride for cavity protection
Helps keep breath minty fresh
Helps whiten enamel
Exposed dentin
Repairing layer protects against sensitivity*
Sensodyne® Repair and Protect toothpaste helps repair* the sensitive areas of your teeth.
#1 Dentist Recommended Brand for Sensitive Teeth
Why use Sensodyne® Repair and Protect?
Now there is a Sensodyne® toothpaste that can help repair sensitive areas of your teeth. The active ingredient in Sensodyne® Repair & Protect acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. It is also specially formulated to help whiten enamel and prevent staining. With regular use, Sensodyne® Repair Protect provides proven relief from sensitivity*.
*With twice daily brushing
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or Licensed to the GSK group of companies
©2014 GSK
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
104999XB
NDC 0135-0547-02
SENSODYNE®
WITH FLUORIDE
DAILY REPAIR* TOOTHPASTE
TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION
NET WT 3.4 oz (96.4g)
#1 Dentist Recommended Brand
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
EXTRA FRESH
REPAIR & PROTECT
Proven relief and protection from sensitivity pain*
Daily protection for sensitive teeth*
Contains fluoride for cavity protection
Leaves your mouth feeling clean and fresh
Helps whiten enamel
Exposed dentin
Repairing layer protects against sensitivity*
Sensodyne® Repair and Protect toothpaste helps repair* the sensitive areas of your teeth.
#1 Dentist Recommended Brand for Sensitive Teeth
Why use Sensodyne® Repair and Protect?
Now there is a Sensodyne® toothpaste that can help repair* sensitive areas of your teeth. The active ingredient in Sensodyne® Repair & Protect acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. It is also specially formulated to help whiten enamel and prevent staining. With regular use, Sensodyne® Repair Protect provides proven relief from sensitivity*.
*With twice daily brushing
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or Licensed to the GSK group of companies.
©2014 GSK
GSK Consumer Healthcare
Warren, NJ 07059
105710XA
NDC 0135-0575-01
SENSODYNE®
WITH FLUORIDE
TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION
REPAIR & PROTECT
WHITENING
NET WT 3.4 oz (96.4g)
DAILY REPAIR* TOOTHPASTE
#1 Dentist Recommended Brand
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
Proven relief and protection from sensitivity pain*
Daily protection for sensitive teeth*
Helps to remove stains for whiter teeth
Contains fluoride for cavity protection
Helps keep breath minty fresh
Sensodyne® Repair and Protect toothpaste helps repair* the sensitive areas of your teeth.
#1 Dentist Recommended Brand for Sensitive Teeth
Why use Sensodyne Repair and Protect Whitening toothpaste?
Sensodyne® Repair & Protect toothpaste helps repair sensitive areas of your teeth. The active ingredient in Sensodyne® Repair & Protect Whitening toothpaste acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. It is also specially formulated to whiten enamel and prevent staining. With regular use, Sensodyne® Repair Protect Whitening toothpaste provides proven relief from sensitivity*.
*With twice daily brushing
Trademarks are owned by or Licensed to the GSK group of companies
©2014 GSK
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
106064XA
ALWAYS FOLLOW THE LABEL
* Please review the disclaimer below.
