Wax Away Earwax Removal System Solution/ Drops
FDA Label NDC 66354-006

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 Wax Away Earwax Removal System (NDC 66354-006). 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 drug facts, active ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

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 Before Use If You Have

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

When Using This Product

  • avoid contact with the eyes

Stop Use And Ask A Doctor If

  • you need to use for more than 4 days
  • excessive earwax remains after use of this product

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

FOR USE IN THE EAR ONLY

Adults and children over 12 years of age:

  • Tilt head sideways and place 5 to 10 drops into ear
  • Tip of applicator should NOT enter ear canal
  • Keep drops in ear for several minutes by keeping head tilted or placing Mack’s® AquaBlock® Earplugs (sold separately) into the ear
  • Use twice daily for up to 4 days if needed, or as directed by a doctor
  • Any wax remaining after the 4-day treatment may be removed by gently rinsing the ear with body-temperature water using the soft rubber bulb ear syringe

    • Children under 12 years of age: consult a doctor

Other Information

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Keep cap in bottle when not in use
  • Ear drops foam on contact with earwax due to release of oxygen. There may be a mild crackling sound.

Inactive Ingredients

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

Questions Or Comments?

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