Otix Ear Wax Removal System Ear Wax And Bulb Kit
FDA Label NDC 15579-839

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bell Pharmaceuticals, Inc. for the product Otix Ear Wax Removal System Ear Wax And Bulb (NDC 15579-839). 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, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children., 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 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 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 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

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap in bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an assoiciated 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?

1-800-328-5890

Package Labeling:

Kit (Kit)

Kit (Kit)

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