{"active_ingredient":["Active ingredient Carbamide peroxide 6.5% Purpose Earwax removal aid"],"dosage_and_administration":["Directions Adults and Children over 12 years of age: Tilt head sideways and place 5 to 10 Earwax Removal Drops into ear Tip of applicator nozzle should NOT enter ear canal With head still sideways, insert earplugs as follows: Reach over head and pull up and back on outer ear to straighten ear canal With opposite hand, grasp earplug stem and insert by pressing forward in a circular motion, just enough to seal in drops. Do not insert deeply into canal. Repeat for other ear, if treating both ears Keep drops in ear(s) for several minutes Remove earplugs slowly with a twisting motion to gradually break the seal Use twice daily for up to four days if needed, or as directed by a doctor Any earwax remaining after the 4-day treatment may be removed by gently rinsing the ear with body-temperature water, using the Bellow Syringe Fill supplied tub 1/3 to 1/2 full with body-temperature water Fully compress Bellow Syringe and insert blue Rinse Tip into water Release the pressure on the Bellow Syringe, allowing the water to be drawn into the bellow While holding tub beneath ear, place the blue Rinse Tip into ear opening and compress bellow to rinse ear canal Children under 12 years of age : Consult a doctor"],"effective_time":"20260209","id":"4a636cb5-104c-7811-e063-6294a90afcb0","inactive_ingredient":["Inactive ingredients anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water"],"indications_and_usage":["Uses for occasional use as an aid to soften, loosen, and remove excessive earwax"],"keep_out_of_reach_of_children":[""],"openfda":{"application_number":["M014"],"brand_name":["ProRinse Earwax Removal System"],"generic_name":["CARBAMIDE PEROXIDE"],"is_original_packager":[true],"manufacturer_name":["McKeon Products Inc"],"package_ndc":["66354-007-82"],"product_ndc":["66354-007"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["702050"],"spl_id":["4a636cb5-104c-7811-e063-6294a90afcb0"],"spl_set_id":["ca82db28-1ef7-41c6-a46b-7bfc7b09281c"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"]},"package_label_principal_display_panel":["Product label image description"],"purpose":["Purpose Earwax removal aid"],"questions":["Questions or comments? Call (586) 427-7560 during business hours (EST)"],"set_id":"ca82db28-1ef7-41c6-a46b-7bfc7b09281c","spl_product_data_elements":["ProRinse Earwax Removal System CARBAMIDE PEROXIDE ANHYDROUS CITRIC ACID GLYCERIN PROPYLENE GLYCOL SODIUM CITRATE SODIUM LAURYL SULFATE WATER CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"spl_unclassified_section":["Drug Facts","Other information Avoid exposing Earwax Removal Drops to excessive heat and sunlight Ear drops foam on contact with earwax due to release of oxygen. There may be an associated “crackling” sound Keep cap on bottle when not in use This system is designed for multiple treatments The components are washable and reusable"],"version":"1","warnings":["Warnings For use in the ear only Ask a doctor or pharmacist before use if you have: ear drainage or discharge recently had ear surgery dizziness pain, irritation, or rash in the ear an ear infection had an injury or perforation (hole) of the eardrum Stop use and ask doctor if : you need to use for more than four days excessive earwax remains after use of this product When using this product , avoid contact with the eyes When using earplugs , do not insert deeply into ear canal. Remove very slowly with a twisting motion to gradually break the seal. Due to the excellent seal characteristics, rapid removal may damage eardrum Keep this and all drugs out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately."]}