{"active_ingredient":["Active ingredient Carbamide peroxide 6.5% Purpose Earwax removal aid"],"ask_doctor":["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 ear drum recently had ear surgery"],"dosage_and_administration":["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 titled 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: consult a doctor"],"effective_time":"20250228","id":"2f394074-9ba2-6dff-e063-6294a90a2cad","inactive_ingredient":["Inactive ingredients anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water"],"indications_and_usage":["Uses for occasional use as an aid to soften, looser, and remove excessive ear wax"],"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":{"application_number":["M014"],"brand_name":["TopCare Earwax Removal Kit"],"generic_name":["CARBAMIDE PEROXIDE"],"is_original_packager":[true],"manufacturer_name":["TOPCO ASSOCIATES LLC"],"package_ndc":["36800-835-33"],"product_ndc":["36800-835"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["702050"],"spl_id":["2f394074-9ba2-6dff-e063-6294a90a2cad"],"spl_set_id":["890cc9b6-41a5-480a-bc94-45c8d4fdeef3"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"],"upc":["0036800776913"]},"other_safety_information":["Other information Avoid exposing bottle to excessive heat and direct sunlight Store bottle in the outer carton Keep cap on bottle when not in use Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling sound Do not use if tamper-evident safety seal is broken or missing"],"package_label_principal_display_panel":["Package Labeling: Label"],"purpose":["Purpose Earwax removal aid"],"questions":["Questions? 1-888-423-0139"],"set_id":"890cc9b6-41a5-480a-bc94-45c8d4fdeef3","spl_product_data_elements":["TopCare Earwax Removal Kit CARBAMIDE PEROXIDE ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL SODIUM CITRATE SODIUM LAURYL SULFATE WATER CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if you need to use for more than 4 days excessive ear wax remains after use of this product"],"version":"7","warnings":["Warnings For use in the ear only 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 ear drum recently had ear surgery When using this product avoid contact with the eyes Stop use and ask a doctor if you need to use for more than 4 days excessive ear wax remains after use of this product Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid contact with the eyes"]}