Ear Drops
FDA Label NDC 24385-955

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisourcebergen Drug Corporation (good Neighbor Pharmacy) for the product Ear Drops (NDC 24385-955). 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, stop use and ask a doctor if, keep out of reach of children, directions, other information, 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.

Warnings

Stop Use And Ask A Doctor If

  • you need to use of r more than 4 days
  • excessive ear wax remains after use of this product

Keep Out Of Reach Of Children

In case of accidental overdose or allergic reaction, get medical help or contact a Poison Control Center immediately

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.
  • Product foams on contact with earwax due to release of oxygen.  There may be an associated crackling.
  • Keep cap on bottle when not in use.
  • Lot no. and exp. date:  see label, bottom container or box.

Inactive Ingredients

Anhydrous Glycerin, Citric Acid, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

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