{"active_ingredient":["Active Ingredients Lidocaine USP 4% Phenylephrine HCl 0.25%"],"ask_doctor":["Ask a doctor before use if you have allergies to any of the components of this product difficulty in urination due to enlargement of the prostate gland Diabetes Heart Disease High Blood Pressure Thyroid Disease presently taking a prescription for high blood pressure or depression"],"dosage_and_administration":["Directions children under 12 years of age consult your pediatrician. adults: apply to affected area up to 4 times daily. cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use. to use dispensing cap, attach it to tube, lubricate well, then apply externally to the skin of the anal canal only. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly"],"effective_time":"20251126","id":"44848a07-eb1f-3040-e063-6294a90a1762","inactive_ingredient":["Inactive Ingedients Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, olea europaea (olive) fruit oil, panax ginseng root extract, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, retinyl palmitate, sodium hyaluronate, stearic acid, tocopheryl acetate, triethoxycaprylysilane, water, zinc oxide"],"indications_and_usage":["Uses temporarily shrinks hemorrhoidal tissue for the temporary relief of pain, soreness, or burning helps relieve the local itching and discomfort associated with hemorrhoids"],"keep_out_of_reach_of_children":["Keep out of reach of children if swallowed, seek medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M015"],"brand_name":["Dr Butlers Hemorrhoid and Fissure PF"],"generic_name":["LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25"],"is_original_packager":[true],"manufacturer_name":["Beyond Health P.A."],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["70942-357-00","70942-357-01","70942-357-07","70942-357-75","70942-357-06","70942-357-12","70942-357-05","70942-357-15"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["70942-357"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2673304"],"spl_id":["44848a07-eb1f-3040-e063-6294a90a1762"],"spl_set_id":["f526199e-5c9e-7a3c-e053-2a95a90aa98e"],"substance_name":["LIDOCAINE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["98PI200987","04JA59TNSJ"]},"package_label_principal_display_panel":["0.75oz / 21.3g tube pdp_tube","Carton of 12 0.07oz / 2g packets pdp_packets"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding as a health care professional before use."],"purpose":["Purpose Analgesic (pain relief) Vasoconstrictor"],"set_id":"f526199e-5c9e-7a3c-e053-2a95a90aa98e","spl_product_data_elements":["Dr Butlers Hemorrhoid and Fissure PF Lidocaine 4.00, Phenylephrine Hydrochloride 0.25 HORSE CHESTNUT ALOE ASCORBIC ACID CALENDULA OFFICINALIS FLOWER CAPRYLHYDROXAMIC ACID CENTELLA ASIATICA CHOLECALCIFEROL SUNFLOWER OIL HYDROCORTISONE LYSINE HYDROCHLORIDE MINERAL OIL CAPRYLIC/CAPRIC TRIGLYCERIDE OLIVE OIL ASIAN GINSENG MATRICARIA CHAMOMILLA FLOWERING TOP OIL PETROLATUM PROPYLENE GLYCOL PUNICA GRANATUM ROOT BARK GLYCERYL CAPRYLATE VITAMIN A PALMITATE LAMINARIA DIGITATA HYALURONATE SODIUM PORPHYRA UMBILICALIS STEARIC ACID .ALPHA.-TOCOPHEROL ACETATE TRIETHOXYCAPRYLYLSILANE WATER GLYCERIN ZINC OXIDE LIDOCAINE LIDOCAINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"spl_unclassified_section":["Other Information store at 15º-30º C (59º-86º F)"],"stop_use":["Stop use and ask a doctor if condition worsens or does not improve within seven (7) days bleeding occurs an allergic reation develops the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase"],"version":"5","warnings":["Warnings For external use only including the skin of the anal canal. When using this product do not exceed recommended dosage unless directed by a doctor when using finger cots or an applicator, apply externally or to the skin of the anal canal only. Do not put this product into the rectum Ask a doctor before use if you have allergies to any of the components of this product difficulty in urination due to enlargement of the prostate gland Diabetes Heart Disease High Blood Pressure Thyroid Disease presently taking a prescription for high blood pressure or depression Stop use and ask a doctor if condition worsens or does not improve within seven (7) days bleeding occurs an allergic reation develops the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding as a health care professional before use. Keep out of reach of children if swallowed, seek medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not exceed recommended dosage unless directed by a doctor when using finger cots or an applicator, apply externally or to the skin of the anal canal only. Do not put this product into the rectum"]}