{"active_ingredient":["Carbamide Peroxide 6.5% non USP* *pH differs from USP specifications"],"dosage_and_administration":["FOR USE IN THE EAR ONLY. Remove any hearing aids before use. Adults and children over 12 years of age: ​tilt head sideways 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 four days if needed, or as directed by a doctor any wax remaining after treatment may be removed by gently flushing ear with warm (body temperature) water, using a soft rubber bulb ear syringe Children under 12 years of age: Consult a physician"],"effective_time":"20260415","id":"4f86b363-aff6-1bfb-e063-6394a90a317f","inactive_ingredient":["Citric acid Flavor Glycerin Propylene Glycol Sodium Lauroyl Sarcosinate Sodium Stannate Purified Water"],"indications_and_usage":["For occasional use as an aid to soften, loosen, and remove excessive earwax."],"keep_out_of_reach_of_children":["If swallowed, get medical help or contact a Posion Control Center right away."],"openfda":{"application_number":["M014"],"brand_name":["Freskaro Earwax Removal Aid"],"generic_name":["CARBAMIDE PEROXIDE 6.50% KIT"],"is_original_packager":[true],"manufacturer_name":["Pharma Nobis, LLC"],"package_ndc":["82645-097-90","82645-097-45"],"product_ndc":["82645-097"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["702050"],"spl_id":["4f86b363-aff6-1bfb-e063-6394a90a317f"],"spl_set_id":["4f5967ee-bc05-341c-e063-6394a90a35c6"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"],"upc":["0382645097905"]},"package_label_principal_display_panel":["Freskaro Earwax Removal Kit 2026 Freskaro Earwax Removal Carton Freskaro Earwax Removal Bottle"],"purpose":["Earwax removal aid"],"set_id":"4f5967ee-bc05-341c-e063-6394a90a35c6","spl_product_data_elements":["Freskaro Earwax Removal Aid carbamide peroxide 6.50% kit SODIUM LAUROYL SARCOSINATE WATER ANHYDROUS CITRIC ACID SODIUM STANNATE GLYCERIN PROPYLENE GLYCOL CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"stop_use":["Stop use and ask a doctor if excessive earwax remains after use of this product for 4 consecutive days."],"version":"2","warnings":["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 ear or after ear surgery, unless directed by a doctor for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor."],"when_using":["When using this product avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor."]}