{"active_ingredient":["Active ingredient Lidocaine 5% w/w"],"dosage_and_administration":["Directions when practical, clean 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":"20260727","id":"579d8135-645f-2dde-e063-6394a90a1803","inactive_ingredient":["Inactive ingredients Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cholesterol, Isopropyl myristate, Mineral Oil, Polysorbate 80, Propylene Glycol, Purified Water, Tocopherol, Trolamine"],"indications_and_usage":["Uses Temporarily relieves pain and itching due to 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 right away."],"openfda":{"application_number":["M017"],"brand_name":["RectoProtect"],"generic_name":["LIDOCAINE"],"is_original_packager":[true],"manufacturer_name":["Akron Pharma Inc."],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["71399-0050-2","71399-0050-1"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["71399-0050"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1366789"],"spl_id":["579d8135-645f-2dde-e063-6394a90a1803"],"spl_set_id":["1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["1 2"],"purpose":["Purpose Local anesthetic"],"questions":["Questions or comments? Call toll-free 1-877-255-6999 Manufactured for: Akron Pharma Inc. Fairfield, Nj 07004 www.akronpharma.com"],"set_id":"1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb","spl_product_data_elements":["RectoProtect Lidocaine LIDOCAINE LIDOCAINE ALOE VERA LEAF BENZYL ALCOHOL CARBOMER CHOLESTEROL ISOPROPYL MYRISTATE MINERAL OIL POLYSORBATE 80 PROPYLENE GLYCOL WATER TOCOPHEROL TROLAMINE clear gel"],"spl_unclassified_section":["Other information May be applied under occlusive dressing. Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature]."],"stop_use":["Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs redness, irritation, swelling, pain or other symptoms begin or increase symptoms clear up and return within a few days"],"version":"5","warnings":["Warnings When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor"],"when_using":["When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor"]}