{"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. To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area."],"effective_time":"20241101","id":"4b196450-e9de-4c85-8652-42d926d951d5","inactive_ingredient":["Inactive Ingredients acrylamide, allantoin, aloe vera extract, benzyl alcohol, C12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloyldimethyl taurate, sodium laureth sulfate, soy lecithin and tocopheryl acetate."],"indications_and_usage":["Uses Helps relieve the pain, itching, and burning associated with other rectal disorders."],"keep_out_of_reach_of_children":["Keep out of reach of of children. If swallowed, get medical help or contact Poison Control Center immediately."],"openfda":{"application_number":["M017"],"brand_name":["LIDOCAINE"],"generic_name":["LIDOCAINE"],"is_original_packager":[true],"manufacturer_name":["STRATUS PHARMACEUTICALS INC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["58980-823-30","58980-823-05"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["58980-823"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1534792"],"spl_id":["4b196450-e9de-4c85-8652-42d926d951d5"],"spl_set_id":["87a4f559-a4f6-4b9f-98de-b55b073a11c6"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 14.17 g Tube Box STRATUS PHARMACEUTICALS INC NDC 58980-823-05 Net WT. 0.5 oz. / 14.17 g LIDOCAINE CREAM 5% ANORECTAL CREAM PRINCIPAL DISPLAY PANEL - 14.17 g Tube Box"],"purpose":["Purpose Local anesthetic"],"set_id":"87a4f559-a4f6-4b9f-98de-b55b073a11c6","spl_product_data_elements":["LIDOCAINE LIDOCAINE LIDOCAINE LIDOCAINE ACRYLAMIDE ALLANTOIN ALOE VERA LEAF BENZYL ALCOHOL ALKYL (C12-15) BENZOATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ISOHEXADECANE POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM ACRYLOYLDIMETHYLTAURATE SODIUM LAURETH-3 SULFATE SOYBEAN LECITHIN .ALPHA.-TOCOPHEROL ACETATE"],"spl_unclassified_section":["Drug Facts","Distributed By: Stratus Pharmaceuticals, Inc.,Miami, FL 33186"],"storage_and_handling":["Other Information Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]."],"version":"5","warnings":["WARNINGS \"Methemoglobinemia Warning\" use of this product may cause; a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used the product before. Stop use and seek immediate medical attention if the following develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy. If pregnant or breast feeding, ask a health provider before use. Keep out of reach of of children. If swallowed, get medical help or contact Poison Control Center immediately."]}