Active Ingredient Purpose
Carbamide Peroxide - 6.50% Earwax removal aid
Ear Wax Removal System
FDA Label NDC 49035-554
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walmart for the product Ear Wax Removal System (NDC 49035-554). 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, keep out of reach of the children, directions for use in the ear only. adults and children over 12 years of age:, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Keep Out Of Reach Of The Children
If product is 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 of age: consult a doctor.
Other Information
• Protect from heat and direct sunlight • Keep cup on bottle when not in use
Inactive Ingredient
Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Water
* Please review the disclaimer below.
