Active Ingredient Purpose
Carbamide Peroxide 6.5% Softens & removes wax
Ear System
FDA Label NDC 24385-501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Ear System (NDC 24385-501). 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, directionsdirections for use in the ear only., inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For occasional use as an aid soften, loosen, and remove excessive ear wax
Warnings
Do not use
• If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor.
• If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor.
When using this product avoid contact with eyes
Stop use and ask a doctor if excessive earwax remains after use of this product for four consecutive days
Directionsdirections 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 of age: consult a doctor.
Inactive Ingredients
Glyceryn, Oxyquinoline
* Please review the disclaimer below.
