Meijer Earwax Removal Drops Solution/ Drops
FDA Label NDC 41250-282

14 label sections · Submitted to the FDA by Meijer Distribution Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Meijer Earwax Removal Drops (NDC 41250-282). 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

Ear wax removal aid

Uses

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

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 ear wax remains after use of this product

Keep Out Of Reach Of Children.

If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) 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 cotton in the ear
  • Use twice daily for up to 4 days if needed, or as directed by a doctor
  • Any wax remaining after treatment my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe

    • Children under 12 years:consult a doctor 0

Other Information

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Do not store above 25°C (77°F)
  • Keep cap on bottle when not in use
  • Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling sound.
  • Do not use if tamper-evident safety seal is broken or missing

Inactive Ingredients

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

Questions?

1-800-328-5890Weekday 8:30-5:00 CST

Package Labeling:

Image Description (Label3)

Image Description (Label3)

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