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  5. Label Information: Sensodyne

FDA Label for Sensodyne

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WHEN USING THIS PRODUCT,
    5. STOP USE AND ASK A DENTIST IF
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL

Sensodyne 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)

**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


Principal Display Panel



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.