{"active_ingredient":["Active Ingredient Dibucaine 1%"],"do_not_use":["Do Not Use In or near eyes In children under 2 years of age"],"dosage_and_administration":["Directions Adults and children 12 years of age or older. If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet tissue or a soft cloth before applying. Apply externally to the affected area up to 3 to 4 times daily. Children under 12 years of age. ask a doctor"],"effective_time":"20241220","id":"29b472b9-6743-2403-e063-6294a90a22d0","inactive_ingredient":["Inactive Ingredients Lanolin, Light Mineral Oil, Purified Water, White Petrolatum"],"indications_and_usage":["Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders."],"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":["M015"],"brand_name":["Dibucaine"],"generic_name":["DIBUCAINE 1%"],"is_original_packager":[true],"manufacturer_name":["Geri-Care Pharmaceuticals, Corp"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["57896-131-01"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["57896-131"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["238784"],"spl_id":["29b472b9-6743-2403-e063-6294a90a22d0"],"spl_set_id":["afe88610-5cac-960e-e053-2a95a90a7ba4"],"substance_name":["DIBUCAINE"],"unii":["L6JW2TJG99"],"upc":["0357896131012"]},"package_label_principal_display_panel":["Packaging gericare-dibucaine-1oz-CDER"],"pregnancy_or_breast_feeding":["If Pregnant or Breast-Feeding Ask a health care professional before use."],"purpose":["Hemorrhoidal Ointment"],"set_id":"afe88610-5cac-960e-e053-2a95a90a7ba4","spl_product_data_elements":["Dibucaine Dibucaine 1% PETROLATUM WATER DIBUCAINE DIBUCAINE LIGHT MINERAL OIL LANOLIN"],"spl_unclassified_section":["Drug Facts","Distributed By Geri-Care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204 1-800-540-3765 Product of China * This product is not manufactured or distributed by the owner of the registered trademark Nupercainal®"],"stop_use":["Stop Use and ask a doctor Bleeding occurs Condition worsens or does not improve within 7 days"],"storage_and_handling":["Other Information Store at 20º-25ºC (68º-77ºF) T amper-evident; do not use if foil seal is broken or missing"],"version":"4","warnings":["Warnings For External use only Allergy alert Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and ask a doctor."],"when_using":["When using this product Do not use more than directed unless directed by a doctor Do not put this product into the rectum by using fingers or any mechanical device or applicator."]}