{"active_ingredient":["Active ingredient Colloidal Oatmeal 5%"],"do_not_use":["Do not use on broken skin"],"dosage_and_administration":["Directions apply generously to affected areas as needed"],"effective_time":"20251202","id":"daa3258e-623a-4eb1-adae-94b38d034006","inactive_ingredient":["Inactive ingredients aloe barbadensis leaf juice powder, benzyl alcohol, butyrospermum parkii (shea) butter, caprylyl glycol, cetostearyl alcohol, decyl oleate, dehydroxanthan gum, glycerin, glyceryl stearate se, isopropyl myristate, water"],"indications_and_usage":["Uses temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak or sumac insect bites"],"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":["M016"],"brand_name":["Flexitol Face and Eyelid Eczema"],"generic_name":["OATMEAL"],"is_original_packager":[true],"manufacturer_name":["LaCorium Health USA Inc."],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","N0000185016"],"package_ndc":["43251-4904-1"],"pharm_class_cs":["Allergens [CS]","Dietary Proteins [CS]","Plant Proteins [CS]"],"pharm_class_epc":["Non-Standardized Food Allergenic Extract [EPC]","Non-Standardized Plant Allergenic Extract [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["43251-4904"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1595494"],"spl_id":["daa3258e-623a-4eb1-adae-94b38d034006"],"spl_set_id":["f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65"],"substance_name":["OATMEAL"],"unii":["8PI54V663Y"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 40 g Tube Carton NDC: 43251-4904-1 Flexitol™ SKIN THERAPY FACE & EYELID ECZEMA CREAM SOOTHING RELIEF FOR DELICATE SKIN CLINICALLY TESTED* Helps relieve red, itchy eczema rashes on face and eyelids With soothing Colloidal Oatmeal 5% Free from cortisone Award winning formula Skin protectant Hypoallergenic Net Wt. 1.4 oz (40g) PRINCIPAL DISPLAY PANEL - 40 g Tube Carton"],"purpose":["Purpose Skin protectant"],"questions":["Questions or Comments? Call Toll Free 1-866-478-3338 usainfo@flexitol.com www.flexitol.com"],"set_id":"f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65","spl_product_data_elements":["Flexitol Face and Eyelid Eczema oatmeal oatmeal oatmeal Water Cetostearyl Alcohol GLYCERYL STEARATE SE Isopropyl Myristate DECYL OLEATE Glycerin BENZYL ALCOHOL SHEA BUTTER Caprylyl glycol Dehydroxanthan gum ALOE VERA LEAF"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY: LaCorium Health USA Inc 801 Broad St, Suite 600 Chattanooga, TN 37402"],"stop_use":["Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days"],"storage_and_handling":["Other Information Store between 50-86°F in a dry place"],"version":"4","warnings":["Warnings For external use only Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days When using this product do not get into eyes Do not use on broken skin Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not get into eyes"]}