Good Neighbor Pharmacy Ear System
FDA Label NDC 24385-503
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 for the product Good Neighbor Pharmacy Ear System (NDC 24385-503). 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 drug facts, active ingredient, purpose, uses, do not use, 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
Active ingredient Purpose
Carbamide Peroxide 6.5%..............................Softens & removes wax
Purpose
Softens & removes wax
Uses
For occasional use as an aid to soften, loosen, and remove
excessive ear wax.
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.
•for more than four consecutive days.
When Using This Product
•avoid contact with the eyes.
Stop Use And Ask A Doctor If
• excessive ear wax remains after
use of this product for four consecutive days.
Keep Out Of Reach Of Children.
If swallowed, get medical help or
contact a Poison Control Center right away. If accidental contact
with eyes occurs, flush eyes with water and consult a doctor.
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 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
• Protect from heat and direct sunlight.
• Keep cap on bottle when not in use.
Inactive Ingredients
Glycerin, Oxyquinoline.
* Please review the disclaimer below.
