{"active_ingredient":["Active Ingredient Carbamide peroxide 6.5%"],"ask_doctor":["Ask your doctor before use if you have ear drainage or discharge have ear pain, irritation or rash in the ear feel dizzy"],"do_not_use":["Do not use this product, unless directed by a doctor if you have an injury or perforation (hole) of the ear drum after ear surgery for more than 4 days"],"dosage_and_administration":["Directions for adults and children 12 years and over, or as directed by a doctor: 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 ear. use twice daily for up to 4 days if needed use a soft, rubber bulb ear syringe to gently flush ear with warm water to remove any wax remaining after treatment Children under 12 years, consult a doctor."],"effective_time":"20180824","id":"b76b7589-8b6d-4767-8bf2-edc928a07804","inactive_ingredient":["Inactive Ingredients citric acid anhydrous, glycerine, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate dihydrate, triethanolamine"],"indications_and_usage":["Uses for occasional use as an aid to soften loosen remove excessive ear wax"],"keep_out_of_reach_of_children":["Keep out of the reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton COMPARE TO ACTIVE INGREDIENT IN DEBROX ®* Rugby ® NDC 0536-1012-94 TAMPER EVIDENT Earwax Treatment Drops Carbamide Peroxide 6.5% Helps Remove Excessive Earwax 1/2 fl oz (15 mL) PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton"],"purpose":["Purpose Ear wax removal aid"],"questions":["Questions or comments? 1-800-645-2158"],"set_id":"5f5b6133-ac36-461a-983b-47c51b1474f4","spl_product_data_elements":["Earwax Treatment Drops Carbamide Peroxide Carbamide Peroxide Hydrogen Peroxide Water Anhydrous Citric Acid Glycerin Sodium Acid Pyrophosphate Trisodium Citrate Dihydrate Propylene Glycol Trolamine Colorloess to pale Yellow"],"spl_unclassified_section":["Drug Facts","Distributed by: Rugby Laboratories 31778 Enterprise Drive Livonia, MI 48150"],"storage_and_handling":["Other information store at 20°-25°C avoid exposure to excessive heat and direct sunlight keep tightly closed see carton or label for lot number and expiration date. TAMPER-EVIDENT: Do not use this product if the imprinted platic seal around the cap of the bottle is cut, torn, broken or missing."],"version":"2","warnings":["Warnings For use in the ear only Do not use this product, unless directed by a doctor if you have an injury or perforation (hole) of the ear drum after ear surgery for more than 4 days Ask your doctor before use if you have ear drainage or discharge have ear pain, irritation or rash in the ear feel dizzy When using this product avoid contact with the eyes Keep out of the reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid contact with the eyes"]}