{"active_ingredient":["Active ingredient(s) Carbamide Peroxide 6.5%"],"ask_doctor":["Ask a doctor before use if you have • ear drainage or discharge • pain, irritation or rash in the ear • had ear surgery • an injury or perforation (hole) in the ear drum"],"do_not_use":["Do not use • In the eye • for more than 4 days"],"dosage_and_administration":["Directions FOR USE IN THE EAR ONLY Adults and children 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 my 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."],"effective_time":"20250410","id":"0eba3457-fa36-4fc5-9688-508442562c29","inactive_ingredient":["Inactive Ingredients anhydrous Glycerin"],"indications_and_usage":["Use(s) For occasional use 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 right away."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel NDC 37205-457-05 LEADER® Ear Drops Earwax Removal Aid Carbamide Peroxide (6.5%) • Softens and removes excessive earwax safely and gently • Safe, fast acting formula SATISFACTION GUARANTEED CONTAINS ONE 0.5 FL. OZ. (15 ML) BOTTLE 6.5% carton"],"purpose":["Purpose Earwax Removal Aid"],"set_id":"010480df-ee44-4f59-93df-42cb4735ff68","spl_product_data_elements":["Earwax Removal Aid Earwax Removal Aid CARBAMIDE PEROXIDE HYDROGEN PEROXIDE GLYCERIN"],"spl_unclassified_section":["Other information Do not use if imprinted seal on cap is broken or missing."],"stop_use":["Stop use and ask a doctor if Stop use and ask a doctor if excessive earwax remains after use"],"storage_and_handling":["Storage • Store at controlled room temperature 15 to 30C (59 to 86F) • KEEP IN A DRY PLACE"],"version":"4","warnings":["Warnings Warning For External Use Only Do not use • In the eye • for more than 4 days Ask a doctor before use if you have • ear drainage or discharge • pain, irritation or rash in the ear • had ear surgery • an injury or perforation (hole) in the ear drum Stop use and ask a doctor if Stop use and ask a doctor if excessive earwax remains after use Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away."]}