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  5. Label Information: Sensodyne Pronamel Clinical Enamel Strength Fresh Breath

FDA Label for Sensodyne Pronamel Clinical Enamel Strength Fresh Breath

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. ADDITIONAL INFORMATION
    11. PRINCIPAL DISPLAY PANEL

Sensodyne Pronamel Clinical Enamel Strength Fresh Breath 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) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing.
    • 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


Additional Information



ALWAYS FOLOW THE LABEL

SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH

CLINICALLY PROVEN ENAMEL STRENGTHENING

REPAIRS

66%of enamel microdamage in the most vulnerable areas of your teeth^

24/7 PROTECTION

against early stage cavities, sensitivity and future enamel damage**

To help protect teeth for life**

LEAVES YOUR MOUTH

feeling clean and fresh

FRESH MINT

*Vs. your mouth’s natural defenses.

**With twice daily brushing.

^Acid weakened enamel. On average as shown in 7 day lab test.


Principal Display Panel



TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PROTECTION

SENSODYNE PRONAMEL

3x STRONGER ENAMEL PROTECTION*

CLINICAL ENAMEL STRENGTH

#1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

FRESH BREATH

NET WT 3.4 OZ (96.4 g)


* Please review the disclaimer below.