{"active_ingredient":["Active ingredient Carbamide peroxide 6.5%"],"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 eardrum 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 place 5 to 10 drops into ear canal. 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 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."],"effective_time":"20251029","id":"424a5b21-d76f-f943-e063-6394a90a50cc","inactive_ingredient":["Inactive ingredients adipic acid, anhydrous glycerin, polysorbate 80"],"indications_and_usage":["Uses For occasional use as an aid to soften, loosen 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 (1-800-222-1222) right away."],"openfda":{"application_number":["M022"],"brand_name":["Ear Wax Removal Aid Drops"],"generic_name":["CARBAMIDE PEROXIDE"],"is_original_packager":[true],"manufacturer_name":["BETTER LIVING BRANDS, LLC"],"package_ndc":["21130-793-15"],"product_ndc":["21130-793"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["702050"],"spl_id":["424a5b21-d76f-f943-e063-6394a90a50cc"],"spl_set_id":["3bded237-4d2c-4b38-bedc-267fdc374194"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"],"upc":["0321130136361","0321130136354"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL *Compare to the active ingredient in Debrox ® Drops NDC 21130-793-15 Ear Wax Removal Aid Drops Carbamide Peroxide 6.5% Ear Wax Removal Aid Safe & Gentle Microfoam Cleansing Action Easy to use Instructions NET WT 0.5 FL OZ (15 mL) TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN DISTRIBUTED BY BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 1-888-723-3929 www.betterlivingbrandsLLC.com IMPORTANT: Keep this carton for future labeling. *This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox ® Drops. Ear Wax Removal Aid Drops Ear Wax Removal KIT 0.5 Fl oz. 15 mL"],"package_label_principal_display_panel_table":["
IMPORTANT:Keep this carton for future labeling.
"],"purpose":["Purpose Earwax removal aid"],"questions":["Questions? 1-866-467-2748"],"set_id":"3bded237-4d2c-4b38-bedc-267fdc374194","spl_product_data_elements":["Ear Wax Removal Aid Drops Carbamide peroxide ADIPIC ACID GLYCERIN POLYSORBATE 80 CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"spl_unclassified_section":["Drug Facts","Other information store at room temperature avoid exposing bottle to excessive heat and direct sunlight store bottle in the outer carton product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound. keep cap on bottle when not in use"],"stop_use":["Stop use and ask a doctor if you need to use for more than four days excessive ear wax remains after use this product"],"version":"6","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 this product avoid contact with the eyes Stop use and ask a doctor if you need to use for more than four days excessive ear wax remains after use this product Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["When using this product avoid contact with the eyes"]}