{"active_ingredient":["Colloidal Oatmeal 0.1%"],"dosage_and_administration":["Directions apply as needed."],"effective_time":"20240915","id":"222b381c-665f-177d-e063-6394a90a3306","inactive_ingredient":["Water, Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Cetearyl Olivate, Sorbitan Olivate, Butyspermum Parkii (Shea) Butter, Sodium Acrylates Copolymer, Glycerin, Inulin, Fucus Vesiculosis (Bladderwrack) Extract, Cetyl Palmitate, Sorbitan Palmitate, Lecithin, Allantoin, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Lactic Acid, Sclerotium Gum, Cyanocobalamin, Pullulan, Silica."],"indications_and_usage":["temporarily protects and helps relieve minor skin irritation and itching due to eczema"],"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":["Whipped Gel"],"generic_name":["COLLOIDAL OATMEAL"],"is_original_packager":[true],"manufacturer_name":["OCEAN OLIVE LLC"],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","N0000185016"],"package_ndc":["84293-010-01","84293-010-02"],"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":["84293-010"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["222b381c-665f-177d-e063-6394a90a3306"],"spl_set_id":["222b381c-665e-177d-e063-6394a90a3306"],"substance_name":["OATMEAL"],"unii":["8PI54V663Y"]},"package_label_principal_display_panel":["Ocean Olive Whipped Gel"],"purpose":["Skin Protectant"],"questions":["Questions or comments? Call toll free 1-800-484-9354 M-F 8am-5pm CST www.ocean-olive.com"],"recent_major_changes":["Mislabeled section"],"set_id":"222b381c-665e-177d-e063-6394a90a3306","spl_product_data_elements":["Whipped Gel Colloidal Oatmeal CETEARYL OLIVATE SORBITAN OLIVATE FUCUS VESICULOSUS SORBITAN MONOPALMITATE LACTIC ACID SUNFLOWER OIL SHEA BUTTER ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) INULIN PHENOXYETHANOL CETYL PALMITATE LECITHIN, SOYBEAN XANTHAN GUM BETASIZOFIRAN PULLULAN WATER PROPANEDIOL GLYCERIN SILICON DIOXIDE ALLANTOIN ETHYLHEXYLGLYCERIN CYANOCOBALAMIN OATMEAL OATMEAL"],"spl_unclassified_section":["OCEAN OLIVE Whipped Gel Nourishing Eczema Spot Treatment Skin Protectant Accepted National Eczema Association 1.7 oz / 50 ml"],"stop_use":["Stop use and consult a doctor if conditions worsen symptoms last more than 7 days or clear up and occur again within a few days"],"version":"1","warnings":["For external use only. When using this product do not get into eyes. Stop use and consult a doctor if conditions worsen symptoms last more than 7 days or clear up and occur again within a few days 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."]}