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  5. Label Information: Sensodyne Pronamel Clinical Enamel Strength Whitening Action

FDA Label for Sensodyne Pronamel Clinical Enamel Strength Whitening Action

View Indications, Usage & Precautions

Table of Contents

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

Sensodyne Pronamel Clinical Enamel Strength Whitening Action 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 Ingredients



Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% 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 25°C (77°F)

Inactive Ingredients



water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, xanthan gum, silica, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide


Questions Or Comments?



1-866-844-2797

ALWAYS FOLLOW THE LABEL


Principal Display Panel



NEW HALEON

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNEPRONAMEL

CLINICAL ENAMEL STRENGTH

3X STRONGER ENAMEL PROTECTION*

# 1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

WHITENING ACTION

NET WT 2.3 OZ (65.2 g)

62000000211437 – Front Carton


* Please review the disclaimer below.