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Debrox Earwax Removal Aid


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient

Carbamide peroxide 6.5% non USP*

*pH differs from USP specifications


Purpose

Earwax removal aid


Uses

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


Warnings


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 eardrum
  • •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 four days
  • •excessive earwax remains after use of this product

Keep this and all drugs out of the 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:

children under 12 years: consult a doctor

  • •tilt head sideways
  • •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 four days if needed, or as directed by a doctor
  • •any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe

Other information

  • •do not store above 25C (77F)
  • •store bottle in the outer carton
  • •product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.
  • •keep tip on bottle when not in use

Inactive ingredients

citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water