{"active_ingredient":["Active Ingredient Lidocaine 5% w/w"],"dosage_and_administration":["Directions When practical, cleanse the affected 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":"20250123","id":"8ab252ef-f8ee-442b-bcf4-a44c57448cba","inactive_ingredient":["Inactive Ingredients Verolec HE 60, Benzyl Alcohol, Polysorbate 80, Triethanolamine, Vitamin E- Acetate, Carbomer 940, Isopropyl Myristate, Propylene Glycol, Water"],"indications_and_usage":["Uses Temporarily relieves the 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":["M015"],"brand_name":["lidocaine"],"generic_name":["LIDOCAINE"],"is_original_packager":[true],"manufacturer_name":["Nivagen Pharmaceuticals, Inc."],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["75834-333-30"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["75834-333"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1366789"],"spl_id":["8ab252ef-f8ee-442b-bcf4-a44c57448cba"],"spl_set_id":["32964ec3-1880-477b-9f71-2222c39106aa"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"],"upc":["0375834333304"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 75834-333-30 Lidocaine 5% Topical Anesthetic Cream-Anorectal NIVAGEN net wt. 30 g (1 oz) carton-label"],"purpose":["Purpose Topical anesthetic"],"set_id":"32964ec3-1880-477b-9f71-2222c39106aa","spl_product_data_elements":["lidocaine lidocaine LIDOCAINE LIDOCAINE HYDROGENATED SOYBEAN LECITHIN BENZYL ALCOHOL POLYSORBATE 80 TRIETHANOLAMINE .ALPHA.-TOCOPHEROL ACETATE CARBOMER 940 ISOPROPYL MYRISTATE PROPYLENE GLYCOL WATER WHITE TO OFF WHITE"],"stop_use":["Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days"],"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]. Inactive Ingredients Verolec HE 60, Benzyl Alcohol, Polysorbate 80, Triethanolamine, Vitamin E- Acetate, Carbomer 940, Isopropyl Myristate, Propylene Glycol, Water Questions? 1-877-977-0687"],"version":"2","warnings":["Warnings For external use only."],"when_using":["When using this product avoid contact with eyes do not use in large quantities, particularly over large surfaces or blistered areas 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"]}