FDA Label for Sensodyne Advanced Whitening

View Indications, Usage & Precautions

Sensodyne Advanced Whitening Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Potassium nitrate 5%**

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


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.

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



  • •Do not store above 30° C (86 °F)

Inactive Ingredients (Advanced Whitening)



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


Questions Or Comments?



1-866-844-2797


Principal Display Panel



NDC 0135-0479-01

SENSODYNE Advanced Whitening

Maximum Strength** with Fluoride

**maximum FDA sensitivity active ingredient

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 6.5 OZ (184 g)

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

#1 Dentist Recommended Brand for Sensitive Teeth

Dentists have been recommending Sensodyne for many years. Sensodyne Advanced Whitening is a fluoride toothpaste. It can be used everyday and provides daily care for sensitive teeth.

Sensodyne is specially formulated to relieve tooth sensitivity. When enamel is worn away or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity pain, for example, with hot and cold food and drinks.

24/7 SENSITIVITY PROTECTION*

24 hr protection*

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

AFTER: Sensodyne Advanced Whitening works inside the tooth to help calm the nerves for 24 hr sensitivity protection.*

*with twice daily brushing

ADVANCED WHITENING

Use Sensodyne Advanced Whitening twice daily:

  • •Long lasting sensitivity protection
  • •Helps bring back the natural whiteness of your teeth
  • •Helps to remove stains for whiter teeth
  • •Provides the benefits of a regular toothpaste
  • This product contains no sugar.

    ALWAYS FOLLOW THE LABEL

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

    ©2020 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    62000000050449


* Please review the disclaimer below.