{"active_ingredient":["Active ingredient(s) Carbamide peroxide 6.5%"],"do_not_use":["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) in the ear drum or after ear surgery, unless directed by a doctor for more than 4 days; if excessive earwax remains after use of this product, consult a doctor"],"dosage_and_administration":["Directions FOR USE IN 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 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. Children under 12 years of age: consult a doctor"],"effective_time":"20251028","id":"4f1c9234-6bb1-4795-af84-731f628424db","inactive_ingredient":["Inactive ingredients citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid"],"indications_and_usage":["Use(s) 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 product is swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M014"],"brand_name":["Carbamide peroxide 6.5%"],"generic_name":["EARWAX REMOVAL KIT"],"is_original_packager":[true],"manufacturer_name":["Allegiant Health"],"package_ndc":["69168-488-68"],"product_ndc":["69168-488"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["702050"],"spl_id":["4f1c9234-6bb1-4795-af84-731f628424db"],"spl_set_id":["54515e9d-2225-4875-a1cf-a24a823300dd"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"]},"package_label_principal_display_panel":["Principal Display Panel Earwax label Ear Wax Carton Earwax label Ear Wax Carton"],"purpose":["Purpose Earwax removal aid"],"questions":["Questions/Comments Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)"],"set_id":"54515e9d-2225-4875-a1cf-a24a823300dd","spl_product_data_elements":["Carbamide peroxide 6.5% Earwax Removal Kit CARBAMIDE PEROXIDE HYDROGEN PEROXIDE CITRIC ACID GLYCERIN PROPYLENE GLYCOL SODIUM CITRATE SODIUM LAURYL SULFATE TARTARIC ACID"],"spl_unclassified_section":["Other information • do not store above 86ºF (30ºC) • protect from heat and direct sunlight • DO NOT USE IF SHRINKBAND ON BOTTLE IS BROKEN OR MISSING • Product foams on contact with earwax due to the release of oxygen. There may be an associated “crackling” sound. • Keep cap on bottle when not in use • Retain carton for full product information."],"version":"2","warnings":["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) in the ear drum or after ear surgery, unless directed by a doctor for more than 4 days; if excessive earwax remains after use of this product, consult a doctor When using this product • avoid contact with eyes. If accidental contact with eyes occurs, flush eyes with water and consult a doctor Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product • avoid contact with eyes. If accidental contact with eyes occurs, flush eyes with water and consult a doctor"]}