{"active_ingredient":["Active Ingredient Active ingredient Purpose Carbamide Peroxide 6.5%..........................Earwax Removal Aid"],"dosage_and_administration":["Directions Directions FOR USE IN THE EAR ONLY Unscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle. 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 ear syringe. - when the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal Children under 12 years of age: consult a doctor. Other information - avoid exposing the bottle to excessive heat and direct sunlight - keep cap on bottle when not in use - lot no. & exp date: see label, bottom of container or box - retain carton for future reference on full labeling - Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated \"cracking\" sound - Note: Oversize packaging for ease in reading label information. Contains one bottle. - Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)"],"effective_time":"20241001","id":"6a4639c2-37ba-4574-b7ef-5e46822577ca","inactive_ingredient":["Inactive Ingredients Inactive ingredients anhydrous glycerin, citric acid, propylene glycol, sodium lauryl sulfate, sodium citrate, tartaric acid"],"indications_and_usage":["Indications and Usage Uses for occasional use as an aid to soften, loosen and remove excessive ear wax."],"keep_out_of_reach_of_children":["Keep Out of Reach of Children 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":["Principal Display Panel NDC 63187-187-15 EAR WAX REMOVER WITH IRRIGATOR Earwax Removal Aid (carbamide peroxide 6.5%) Distributed by: MAJOR PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150 USA Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320 63187-187-15"],"purpose":["Uses Uses for occasional use as an aid to soften, loosen and remove excessive ear wax."],"set_id":"cd054ea1-2bfa-4814-bd88-618c4b8f04b5","spl_product_data_elements":["Ear Wax Remover CARBAMIDE PEROXIDE CARBAMIDE PEROXIDE HYDROGEN PEROXIDE WATER GLYCERIN PROPYLENE GLYCOL CITRIC ACID MONOHYDRATE SODIUM LAURYL SULFATE SODIUM CITRATE, UNSPECIFIED FORM GLYCERYL 1-DIACETYLTARTRATE 2,3-DISTEARATE"],"spl_unclassified_section":["Questions? Adverse Drug Event Call toll free: (800) 616-2471"],"version":"4","warnings":["Warnings Warnings Ask a doctor before use if you have - ear drainage or discharge - ear pain - irritation or rash in the ear - dizziness - an injury or perforation (hole) of the ear drum - recently had ear surgery Stop use and ask a doctor if - you need to use for more than four days - excessive wax remains after use of this product When using this product - avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult your doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away"]}