Ear Wax Removal Aid Drops Liquid
FDA Label NDC 68016-793

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Ear Wax Removal Aid Drops (NDC 68016-793). 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, 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., directions, 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 ear wax

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 ear wax remains after use this product

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

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 canal.
  • ▪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.

    • Children under 12 years of age: consult a doctor.

Other Information

  • ▪Store at room temperature
  • ▪Avoid exposing bottle to excessive heat and direct sunlight
  • ▪Store bottle in the outer carton
  • ▪Product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound.
  • ▪Keep cap on bottle when not in use

Inactive Ingredients

adipic acid, anhydrous glycerin, polysorbate 80.

Questions Or Comments?

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