Active Ingredients
Potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Sensodyne Paste
FDA Label NDC 0135-0702
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 0135-0702). 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, warnings, 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
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.
Warnings
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 betaine, sodium hydroxide, carrageenan, sodium saccharin
Questions Or Comments?
1-866-844-2797
Other (Enamel Strengthening)
ALWAYS FOLLOW THE LABEL
SENSODYNE
CLINICAL
WHITE
CLINICAL PROVEN
WHITENING
DESIGNED FOR
SENSITIVE TEETH
WHITENING
Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains
Strengthens enamel
ENAMEL SAFE
* As shown in an 8 week study.
** With twice daily brushing.
Distributed by: Haleon, Warren, NJ 07059
Trademarks owned or licensed by Haleon.
© 2023 Haleon or licensor.
Other (Stain Protector)
ALWAYS FOLLOW THE LABEL
SENSODYNE
CLINICAL
WHITE
CLINICAL 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
Helps protect teeth from future stains
ENAMEL SAFE
* As shown in an 8 week study.
** With twice daily brushing.
Distributed by: Haleon, Warren, NJ 07059
Trademarks owned or licensed by Haleon.
© 2023 Haleon or licensor.
Principal Display Panel (Enamel Strengthening)
NEW
#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH
SENSODYNE
TOOTHPASE FOR SENSITIVE TEETH AND CAVITY PREVENTION
2 SHADES WHITER TEETH*
+24/7 SENSITIVITY PROTECTION**
CLINICAL
WHITE
ENAMEL STRENGTHENING
NET WT 2.3 OZ (65.2 g)
Principal Display Panel (Stain Protector)
NEW
#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH
SENSODYNE
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
2 SHADES WHITER TEETH*
+24/7 SENSITIVITY PROTECTION**
CLINICAL
WHITE
STAIN PROTECTOR
NET WT 3.4 OZ (96.4 g)
* Please review the disclaimer below.
