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  5. Label Information: Sensodyne Pronamel Intensive Enamel Repair Extra Fresh

FDA Label for Sensodyne Pronamel Intensive Enamel Repair Extra Fresh

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. DIRECTIONS
    5. OTHER INFORMATION
    6. INACTIVE INGREDIENTS (CLEAN MINT)
    7. INACTIVE INGREDIENTS (EXTRA FRESH)
    8. QUESTIONS OR COMMENTS?
    9. PRINCIPAL DISPLAY PANEL (CLEAN MINT)
    10. PRINCIPAL DISPLAY PANEL (EXTRA FRESH)

Sensodyne Pronamel Intensive Enamel Repair Extra Fresh 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



Sodium fluoride 0.05% (0.02% w/v fluoride ion)


Purpose



Anticavity


Uses



• aids in the prevention of dental cavities.

• the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence of dental cavities.


Directions



• adults and children 6 years of age and older:

  •  • use once a day after brushing your teeth with a toothpaste.
  •  • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark.
  •  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
  •  • do not swallow the rinse.
  •  • do not drink from the bottle.
  •  • do not rinse mouth with water.
  •  • do not eat or drink for 30 minutes after rinsing.
  •  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
  •  • supervise children as necessary until capable of using without supervision.

    • • children under 6 years of age: Consult a dentist or doctor.


Other Information



• do not store above 25°C (77°F)

Re-mineralizing action for strong and protected teeth*

  • ✓Alcohol Free**
  • ✓SLS Free
  • ✓Paraben Free
  • ✓Dye Free

    • ALWAYS FOLLOW THE LABEL

    Do not use if printed safety seal around cap is broken or missing.

    *when used as directed with a fluoride toothpaste
    **contains no ethanol

    Distributed by: Haleon, Warren, NJ 07059
    Trademarks are owned or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor.

    Made in Taiwan


Inactive Ingredients (Clean Mint)



water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate


Inactive Ingredients (Extra Fresh)



water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate, FD&C blue no. 1


Questions Or Comments?



1-866-844-2797


Principal Display Panel (Clean Mint)



New

SENSODYNE

PRONAMEL

ANTICAVITY FLUORIDE MOUTHWASH

INTENSIVE ENAMEL

REPAIR

CLEAN MINT

Cavity
Protection

Alcohol
Free**

Helps actively repair weakened enamel*

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

Front: 204828

Back: 204832


Principal Display Panel (Extra Fresh)



New

SENSODYNE

PRONAMEL

ANTICAVITY FLUORIDE MOUTHWASH

INTENSIVE ENAMEL

REPAIR

EXTRA FRESH

Cavity
Protection

Alcohol
Free**

Helps actively repair weakened enamel*

IMPORTANT: Read directions for proper use

16.9 FL OZ (500 mL)

Front: 204830

Back: 204831


* Please review the disclaimer below.