{"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":"20241113","id":"8baec15b-0d92-4e92-acd5-2c6cfa9083b9","inactive_ingredient":["Inactive ingredients Benzyl Alcohol, Carbomer, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate"],"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":["M015"],"brand_name":["Lidocaine Anorectal"],"generic_name":["LIDOCAINE"],"is_original_packager":[true],"manufacturer_name":["Patrin Pharma, Inc"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["39328-025-15","39328-025-30"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["39328-025"],"product_type":["HUMAN OTC DRUG"],"route":["RECTAL"],"rxcui":["1366789"],"spl_id":["8baec15b-0d92-4e92-acd5-2c6cfa9083b9"],"spl_set_id":["456d41fe-8449-4980-9291-d7a3b65a900d"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton NDC 39328-025-30 Lidocaine 5% Anorectal Cream PATRIN PHARMA Net Wt. 30 grams PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton"],"purpose":["Purpose Local anesthetic"],"questions":["Questions? Call 800-936-3088"],"set_id":"456d41fe-8449-4980-9291-d7a3b65a900d","spl_product_data_elements":["Lidocaine Anorectal Lidocaine Lidocaine Lidocaine Benzyl Alcohol CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) HYDROGENATED SOYBEAN LECITHIN Isopropyl Myristate Polysorbate 80 Propylene Glycol WATER Trolamine .ALPHA.-TOCOPHEROL ACETATE"],"spl_unclassified_section":["Drug Facts"],"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"],"storage_and_handling":["Other information Store at room temperature 20–25°C (68–77°F); Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature]."],"version":"2","warnings":["Warnings When using this product Avoid contact with eyes Do not exceed recommended dosage unless directed by a doctor 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}