{"active_ingredient":["Carbamide Peroxide 6.5%"],"dosage_and_administration":["FOR USE IN THE EAR ONLY Adults & Children over 12 yrs of age: Tilt head to the side and place 5-10 drops into ear. Dropper tip of removal drops 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. Safely scoop out wax with removal tool. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe. Children under 12 yrs of age: Consult a doctor."],"effective_time":"20231219","id":"0ce5bdec-f500-73d9-e063-6294a90a6a87","inactive_ingredient":["Aloe Barbadensis Leaf Extract Chamomilla Recutita (Matricaria) Flower Extract Glycerin Mineral Oil Oxyquinoline Sulfate"],"indications_and_usage":["For occasional use as an aid to soften, loosen and remove excessive earwax."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away."],"openfda":{"application_number":["M014"],"brand_name":["Earwax Removal Drops"],"generic_name":["CARBAMIDE PEROXIDE 6.5%"],"is_original_packager":[true],"manufacturer_name":["Randob Labs, Ltd."],"package_ndc":["52412-600-05"],"product_ndc":["52412-600"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"spl_id":["0ce5bdec-f500-73d9-e063-6294a90a6a87"],"spl_set_id":["a9904b63-27a4-205c-e053-2995a90af762"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"]},"other_safety_information":["Other Information Do not use if neck wrap imprinted safety seal is broken or missing Do not store above 25 degrees C, 77 degrees F Store bottle in outer carton Keep cap on bottle when not in use Product foams on contacy with earwax due to release of oxygen"],"package_label_principal_display_panel":["ERO Label.jpg ERO IFC.jpg"],"purpose":["Earwax Removal Aid"],"set_id":"a9904b63-27a4-205c-e053-2995a90af762","spl_product_data_elements":["Earwax Removal Drops Carbamide Peroxide 6.5% CHAMOMILE OXYQUINOLINE SULFATE MINERAL OIL ALOE VERA LEAF GLYCERIN CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"stop_use":["Stop use and ask a doctor if: you need to use more than four days excessive earwax remains after use of this product"],"version":"4","warnings":["Warnings 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":["When using this product avoid contact with eyes."]}