{"active_ingredient":["Active Ingredient Lidocaine USP 5.0%"],"dosage_and_administration":["Directions When practical, cleanse the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor."],"effective_time":"20250930","id":"40079b30-9401-2783-e063-6394a90acd0b","inactive_ingredient":["Inactive ingredients Aesculus Hippocastanum (Horse Chestnut) Extract, Benzyl Alcohol, Calendula Officinalis Flower Extract, Carbomer, Carya Ovata Bark Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Curcuma Longa (Turmeric) Root Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Helichrysum Italicum Extract, Hydrogenated Lecithin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract, Polysorbate 80, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water."],"indications_and_usage":["Uses Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Cener right away."],"openfda":{"application_number":["M015"],"brand_name":["Doctor Butlers Hemorrhoid and Fissure External Pain Formula"],"generic_name":["LIDOCAINE 5%"],"is_original_packager":[true],"manufacturer_name":["Beyond Health, P.A."],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["70942-121-01","70942-121-11","70942-121-07","70942-121-75","70942-121-42"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["70942-121"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1366789"],"spl_id":["40079b30-9401-2783-e063-6394a90acd0b"],"spl_set_id":["d92f22a7-c0b5-d8b8-e053-2a95a90a2376"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["0.75 oz / 21.3g tube PDP","1.5oz / 42.5g jar pdp_jar"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health care professional before use"],"purpose":["Purpose Analgesic (pain reliever)"],"set_id":"d92f22a7-c0b5-d8b8-e053-2a95a90a2376","spl_product_data_elements":["Doctor Butlers Hemorrhoid and Fissure External Pain Formula Lidocaine 5% MELALEUCA ALTERNIFOLIA LEAF TURMERIC HAMAMELIS VIRGINIANA LEAF CARYA OVATA BARK CALENDULA OFFICINALIS FLOWER CENTELLA ASIATICA TRITERPENOIDS OLEA EUROPAEA LEAF BENZYL ALCOHOL CARBOMER 940 POLYSORBATE 80 CHOLESTEROL HYDROGENATED SOYBEAN LECITHIN ISOPROPYL MYRISTATE PROPYLENE GLYCOL WATER TROLAMINE .ALPHA.-TOCOPHEROL ACETATE HORSE CHESTNUT ASIAN GINSENG LAVANDULA ANGUSTIFOLIA FLOWER ROSEMARY MATRICARIA CHAMOMILLA HELICHRYSUM ITALICUM FLOWER LIDOCAINE LIDOCAINE HYALURONATE SODIUM"],"spl_unclassified_section":["Other information store at 15º-30º C (59ºto 86º F)"],"stop_use":["Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reactions to ilgredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase"],"version":"6","warnings":["Warnings For external use only including the skin of the anal canal When using this product avoid contact with eyes do not exceed recommended dosage 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 rectal bleeding occurs condition worsens or does not improve within 7 days allergic reactions to ilgredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding ask a health care professional before use Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Cener right away."],"when_using":["When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator"]}