Prorinse Earwax Removal System Solution/ Drops
FDA Label NDC 66354-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckeon Products Inc for the product Prorinse Earwax Removal System (NDC 66354-007). 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, warnings, directions, other information, inactive ingredients, 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

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

Warnings

For use in the ear only

Ask a doctor or pharmacist before use if you have:

  • ear drainage or discharge
  • recently had ear surgery
  • dizziness
  • pain, irritation, or rash in the ear
  • an ear infection
  • had an injury or perforation (hole) of the eardrum

    • Stop use and ask doctor if:

    • you need to use for more than four days
    • excessive earwax remains after use of this product

      • When using this product, avoid contact with the eyes

      When using earplugs, do not insert deeply into ear canal. Remove very slowly with a twisting motion to gradually break the seal. Due to the excellent seal characteristics, rapid removal may damage eardrum

      Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Adults and Children over 12 years of age:

  • Tilt head sideways and place 5 to 10 Earwax Removal Drops into ear

    • Tip of applicator nozzle should NOT enter ear canal

    • With head still sideways, insert earplugs as follows:

      • Reach over head and pull up and back on outer ear to straighten ear canal

      With opposite hand, grasp earplug stem and insert by pressing forward in a circular motion, just enough to seal in drops. Do not insert deeply into canal.

      • Repeat for other ear, if treating both ears
      • Keep drops in ear(s) for several minutes
      • Remove earplugs slowly with a twisting motion to gradually break the seal
      • Use twice daily for up to four days if needed, or as directed by a doctor
      • Any earwax remaining after the 4-day treatment may be removed by gently rinsing the ear with body-temperature water, using the Bellow Syringe

        • Fill supplied tub 1/3 to 1/2 full with body-temperature water

        Fully compress Bellow Syringe and insert blue Rinse Tip into water

        Release the pressure on the Bellow Syringe, allowing the water to be drawn into the bellow

        While holding tub beneath ear, place the blue Rinse Tip into ear opening and compress bellow to rinse ear canal

        Children under 12 years of age: Consult a doctor

Other Information

  • Avoid exposing Earwax Removal Drops to excessive heat and sunlight
  • Ear drops foam on contact with earwax due to release of oxygen. There may be an associated “crackling” sound
  • Keep cap on bottle when not in use
  • This system is designed for multiple treatments
  • The components are washable and reusable

Inactive Ingredients

  • anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions Or Comments?

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