{"active_ingredient":["​Active ingredient Dibucaine 1% ​Purpose Local Anesthetic"],"do_not_use":["Do not use in or near the eyes in children under 2 years of age"],"dosage_and_administration":["​Directions adults and children 12 years and over: 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":"20250529","id":"364c388d-adc9-9763-e063-6294a90a77cd","inactive_ingredient":["undefined Lanolin, Light Mineral Oil, Purified Water, White Petrolatum"],"indications_and_usage":["​Use temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away."],"openfda":{"application_number":["M015"],"brand_name":["Dibucaine Topical Anesthetic 1% Hemorrhoidal"],"generic_name":["DIBUCAINE"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["0536-1211-95"],"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":["0536-1211"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["198601"],"spl_id":["364c388d-adc9-9763-e063-6294a90a77cd"],"spl_set_id":["f23c8cd1-98f9-41cd-84d4-cf01c2ede29a"],"substance_name":["DIBUCAINE"],"unii":["L6JW2TJG99"],"upc":["0305361211950"]},"package_label_principal_display_panel":["Package Labeling: Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health care professional before use."],"purpose":["​Purpose Local Anesthetic"],"questions":["Questions or comments? call 1-800-639-3803"],"set_id":"f23c8cd1-98f9-41cd-84d4-cf01c2ede29a","spl_product_data_elements":["Dibucaine Topical Anesthetic 1% Hemorrhoidal DIBUCAINE LANOLIN LIGHT MINERAL OIL WATER PETROLATUM DIBUCAINE DIBUCAINE"],"spl_unclassified_section":["​Drug Facts","​Other information Store at 20 o -25 o ​C (68 o -77 o ​F) ​ tamper-evident: do not use if foil seal is broken or missing"],"stop_use":["Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days"],"version":"6","warnings":["​Warnings ​For external use only. Allergy Alert Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritaion, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor. Do not use in or near the eyes in children under 2 years of age 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 Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days If pregnant or breast-feeding ask a health care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away."],"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"]}