{"active_ingredient":["Active ingredients Carbamide Peroxide 6.5% non USP* *pH differs from USP specifications"],"do_not_use":["Do not use if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor If you have an injury or perforation (hole) of the ear or after ear surgery, unless directed by a doctor for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor."],"dosage_and_administration":["Directions FOR USE IN THE EAR ONLY Remove any earing aids before use Adults and children over 12 yrs of age: tilt head to the side and place 10 drops into the ear. Tip of applicator should not enter into the ear canal Keep drops in ear for several minutes by keeping head tilted sideways 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 yrs of age: Consult a physician."],"effective_time":"20260427","id":"507543ad-0cd9-75be-e063-6394a90aee95","inactive_ingredient":["Inactive ingredients Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water."],"indications_and_usage":["Uses For occasional use as an aid to soften, loosen and remove excessive earwax"],"keep_out_of_reach_of_children":["Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M014"],"brand_name":["ear drops"],"generic_name":["CARBAMIDE PEROXIDE 6.5%"],"is_original_packager":[true],"manufacturer_name":["Bionpharma Inc."],"package_ndc":["69452-377-95","69452-377-75"],"product_ndc":["69452-377"],"product_type":["HUMAN OTC DRUG"],"route":["AURICULAR (OTIC)"],"rxcui":["702050"],"spl_id":["507543ad-0cd9-75be-e063-6394a90aee95"],"spl_set_id":["e8bcf92c-ad32-49d5-e053-2995a90ae0c6"],"substance_name":["CARBAMIDE PEROXIDE"],"unii":["31PZ2VAU81"]},"package_label_principal_display_panel":["Carton labeling *compare to the active ingredient in Debrox® Earwax Removal Aid twin pack a+health™ ear drops carbamide peroxide 6.5% earwax removal aid safe, gentle, non-irritating easily cleanses ear with microfoam action 1 fl oz (30mL) two bottles 0.5 fl oz (15 mL) each Carton"],"purpose":["Purposes Earwax removal aid"],"set_id":"e8bcf92c-ad32-49d5-e053-2995a90ae0c6","spl_product_data_elements":["ear drops Carbamide Peroxide 6.5% ANHYDROUS CITRIC ACID SODIUM STANNATE SODIUM LAUROYL SARCOSINATE PROPYLENE GLYCOL WATER GLYCERIN CARBAMIDE PEROXIDE HYDROGEN PEROXIDE"],"spl_unclassified_section":["Other information do not store above 77°F (25°C) store bottle in outer carton product foams on contact with ear was due to the release of oxygen. There may be an associated “crackling” sound. keep cap on bottle when not in use","Questions & comments? call toll free 1-888-235-2466","a+health™ ear drops carbamide peroxide 6.5% earwax removal aid SEALED FOR YOUR PROTECTION. DO NOT USE IF SHRINKBAND ON BOTTLE IS BROKEN OR MISSING AT TIME OF PURCHASE. * Debrox ® is a registered trademark of Medtech Products, Inc. This product is not affiliated with, manufactured, distributed or endorsed by Medtech Products, Inc. Inc., owner of the registered trademark Debrox ® . DISTRIBUTED BY: Bionpharma Inc. , Princeton, NJ 08540 L0001185 R1125"],"stop_use":["Stop use and ask a doctor you need to use for more than four days excessive earwax remains after a four day treatment with this product"],"version":"4","warnings":["Warnings Do not use if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor If you have an injury or perforation (hole) of the ear or after ear surgery, unless directed by a doctor for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor. When using this product avoid contact with eyes Stop use and ask a doctor you need to use for more than four days excessive earwax remains after a four day treatment with this product Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product avoid contact with eyes Stop use and ask a doctor you need to use for more than four days excessive earwax remains after a four day treatment with this product"]}