Debrox Liquid
FDA Label NDC 50090-4201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Debrox (NDC 50090-4201). 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 other, active ingredient, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep this and all drugs out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

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:

  • 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 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

    • children under 12 years: consult a doctor

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

Questions?

1-866-255-5202   Debrox.com

How Supplied

Product: 50090-4201

NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

* Please review the disclaimer below.