{"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":"20201110","id":"107b5a32-577f-4153-a28e-8d62b9568e69","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 68788-6439-1 TAMPER EVIDENT Earwax Treatment Drops Carbamide Peroxide 6.5% Helps Remove Excessive Earwax 1/2 fl oz (15 mL) Repackaged By: Preferred Pharmaceuticals Inc. Ear Drops Carbamide Peroxide 6.5 percent"],"purpose":["Purpose Ear wax removal aid"],"questions":["Questions or comments? 1-800-645-2158"],"set_id":"7006b786-ec05-44b1-b5b2-be07bc2219da","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 Repackaged By: Preferred Pharmaceuticals Inc."],"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":"5","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"]}