{"active_ingredient":["Carbamide Peroxide 6.5%"],"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 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":"20220725","id":"e4a47131-8018-3d92-e053-2a95a90a619e","inactive_ingredient":["Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, 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 Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["DRUG: Ear DropsMajor Major GENERIC: Carbamide Peroxide 6.5% DOSAGE: LIQUID ADMINSTRATION: AURICULAR (OTIC) NDC: 70518-0524-0 NDC: 70518-0524-1 PACKAGING: 15 mL in 1 BOTTLE OUTER PACKAGING: 1 in 1 CARTON ACTIVE INGREDIENT(S): CARBAMIDE PEROXIDE 6.5g in 100mL INACTIVE INGREDIENT(S): SODIUM STANNATE GLYCERIN ANHYDROUS CITRIC ACID PROPYLENE GLYCOL SODIUM LAUROYL SARCOSINATE WATER Remedy_Label MM2"],"purpose":["Earwax Removal Aid"],"set_id":"465f62ef-38d5-4bca-8659-dedcef119ac5","spl_product_data_elements":["Ear Drops Major Carbamide Peroxide 6.5% PROPYLENE GLYCOL SODIUM LAUROYL SARCOSINATE WATER CARBAMIDE PEROXIDE HYDROGEN PEROXIDE SODIUM STANNATE GLYCERIN ANHYDROUS CITRIC ACID"],"version":"5","warnings":["Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery When using this product avoid contact with eyes Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product Stop use and ask a doctor if ​you need to use for more than four days • excessive earwax remains after use of this product Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away"]}