Sensodyne Pronamel Liquid
FDA Label NDC 0135-0451

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Sensodyne Pronamel (NDC 0135-0451). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, directions, other information, inactive ingredients (clean mint), inactive ingredients (extra fresh), questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.