{"active_ingredient":["Active ingredient Colloidal oatmeal 1%"],"ask_doctor":["Stop use and ask a doctor 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"],"dosage_and_administration":["Directions Apply as needed. For targeted areas on body, face and hands."],"effective_time":"20241106","id":"26443c1f-2af2-eaf3-e063-6294a90acf57","inactive_ingredient":["Inactive ingredients Water (aqua), Propanediol, Caprylic/capric triglyceride, Glyceryl stearate, Cetearyl alcohol, Cetyl alcohol, Glycerin, 1,2 Hexanediol, Arginine, Caprylyl glycol, Ceramide NP, Citric acid, Maltodextrin, Oenothera biennis (evening primrose) oil, Ophiopogon japonicus root extract, Polyacrylate-13, Polyisobutene, Polysorbate 20, Sodium benzoate, Sodium hydroxide, Sorbitan isostearate, Tocopherol."],"indications_and_usage":["Uses Temporarily protects and helps relieve minor skin irritation and itching due to: Eczema Rashes"],"keep_out_of_reach_of_children":["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":["Avene XERACALM Eczema Calming Relief Balm"],"generic_name":["COLLOIDAL OATMEAL"],"is_original_packager":[true],"manufacturer_name":["Pierre Fabre USA Inc."],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","N0000185016"],"package_ndc":["64760-777-01","64760-777-02"],"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":["64760-777"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["240651"],"spl_id":["26443c1f-2af2-eaf3-e063-6294a90acf57"],"spl_set_id":["1315f006-0e96-2074-e063-6394a90a6037"],"substance_name":["OATMEAL"],"unii":["8PI54V663Y"]},"package_label_principal_display_panel":["Tube 337123 Tube 337123"],"purpose":["Purpose Skin protectant"],"questions":["Questions? 1-866-41-AVENE (28363)."],"set_id":"1315f006-0e96-2074-e063-6394a90a6037","spl_product_data_elements":["Avene XERACALM Eczema Calming Relief Balm Colloidal oatmeal POLYSORBATE 20 SORBITAN ISOSTEARATE SODIUM BENZOATE 1,2-HEXANEDIOL WATER OATMEAL OATMEAL CETOSTEARYL ALCOHOL ARGININE CAPRYLYL GLYCOL PROPANEDIOL GLYCERYL MONOSTEARATE CETYL ALCOHOL GLYCERIN ACONITIC ACID MALTODEXTRIN EVENING PRIMROSE OIL POLYACRYLATE-13 POLYISOBUTYLENE (1000 MW) OPHIOPOGON JAPONICUS ROOT TOCOPHEROL CERAMIDE NP SODIUM HYDROXIDE MEDIUM-CHAIN TRIGLYCERIDES"],"spl_unclassified_section":["Drug Facts"],"version":"3","warnings":["Warnings For external use only."],"when_using":["When using this product When using this product - do not get into eyes"]}