{"active_ingredient":["Active Ingredient Lidocaine 5% w/w"],"dosage_and_administration":["Directions Directions: When practical, clean the affected area with mild soaping warm water and rinse thoroughly. Gently dry by patting or blotting with a toilet tissue or soft cloth before applying. Adult and children 12 years of age and older, apply to affected area not more than 6 times a day. Children under 12 years of age: do not use, ask a doctor"],"effective_time":"20260720","id":"57165430-c79f-2013-e063-6294a90a03be","inactive_ingredient":["Inactive Ingredients Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl myristate, Propylene glycol,Trolamine, Vitamin E, polysorbate 80, propylene glycol, purified water"],"indications_and_usage":["Uses Helps relieve the pain, ithcing and burning associated with hemorrhoids and other 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":["RectaEase Hemorrhoid Relief Cream"],"generic_name":["LIDOCAINE"],"is_original_packager":[true],"manufacturer_name":["Trifecta Pharmaceuticals USA LLC"],"nui":["N0000175682","M0000897","N0000175426","N0000175976"],"package_ndc":["69396-070-01","69396-070-22","69396-070-33"],"pharm_class_cs":["Amides [CS]"],"pharm_class_epc":["Amide Local Anesthetic [EPC]","Antiarrhythmic [EPC]"],"pharm_class_pe":["Local Anesthesia [PE]"],"product_ndc":["69396-070"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1366789"],"spl_id":["57165430-c79f-2013-e063-6294a90a03be"],"spl_set_id":["c054921a-9f1b-7c75-e053-2995a90a1738"],"substance_name":["LIDOCAINE"],"unii":["98PI200987"],"upc":["0860003665770"]},"package_label_principal_display_panel":["Packaging 4074 RECTAEASE HEMORRHID RELIEF CREAM WITH 5 PERCENT LIDOCAINE 1OZ NO FINGER COTS CDER 2 4074 RECTAEASE HEMORRHID RELIEF CREAM WITH 5 PERCENT LIDOCAINE 1OZ NO FINGER","Packaging Recta east Hemorrhoidal Relief Cream 1oz 3pk_box CDER 120125","Packaging Recta ease Hemorrhoidal Relief Cream 1oz 2pk_box CDER 120125 Recta ease Hemorrhoidal Relief Cream 1oz 3pk_box CDER 120125"],"pregnancy_or_breast_feeding":["If Pregnant or Breast Feeding Ask doctor before use"],"purpose":["Purpose Local Anesthetic"],"questions":["Questions or Comments Call 1-888-296-9067"],"set_id":"c054921a-9f1b-7c75-e053-2995a90a1738","spl_product_data_elements":["RectaEase Hemorrhoid Relief Cream Lidocaine LIDOCAINE LIDOCAINE POLYSORBATE 80 BENZYL ALCOHOL PROPYLENE GLYCOL WATER ALPHA-TOCOPHEROL ACETATE CHOLESTEROL ISOPROPYL MYRISTATE LIGHT MINERAL OIL ALOE BARBADENSIS LEAF JUICE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE SODIUM HYDROXIDE"],"spl_unclassified_section":["Drug Facts","Other Information Store at 20º-25ºC (68º-77ºF)","Distributed By Trifecta Pharmaceuticals USA™ 101 NE Third Avenue, Suite 1500 Ft. Lauderdale, FL. 33301, USA 1-888-296-9067 www.trifecta-pharma.com"],"stop_use":["Stop use and ask a doctor Rectal bleeding occurs Condition worsens Symptoms persist for more than 7 days or clear up and return within a few days Symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase."],"version":"7","warnings":["Warning Section For External Use Only"],"when_using":["When using this product Avoid contact with the eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator"]}