{"active_ingredient":["Active Ingredient Colloidal Oatmeal 2%"],"dosage_and_administration":["Directions • Apply to affected areas of skin twice daily"],"effective_time":"20251224","id":"600612eb-7f2c-42b7-8b2a-6eb01342aa66","inactive_ingredient":["Inactive Ingredients Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Cetyl Palmitate, Dimethicone, DMDM Hydantoin, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Mineral Oil, Octyldodecanol, PEG-40 Stearate, Phenoxy Ethanol, Sodium Hydroxide, Water"],"indications_and_usage":["Uses • Temporarily protects and helps relieve minor skin irritation and itching due to dry skin and 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":["TCX Skincare"],"generic_name":["COLLOIDAL OATMEAL"],"is_original_packager":[true],"manufacturer_name":["Theraceutix, LLC"],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","N0000185016"],"package_ndc":["49449-100-01","49449-100-02"],"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":["49449-100"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1189915"],"spl_id":["600612eb-7f2c-42b7-8b2a-6eb01342aa66"],"spl_set_id":["c3be950b-28cf-47c2-9570-ebd46e43b1ba"],"substance_name":["OATMEAL"],"unii":["8PI54V663Y"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel - Carton Label ECZEMA AND DRY SKIN RELIEF Skin Protectant tcx skincare ® UNIQUE HYDROMIMETICS ™ 2 fl oz/59 mL Carton Label image-01","Package/Label Principal Display Panel - Sample Label tcx skincare ® UNIQUE HYDROMIMETICS ™ 0.3 oz Eczema and Dry Skin Relief Skin Protectant Directions: Apply to affected areas of skin twice daily SAMPLE NOT FOR RESALE tcxskincare.com Sample Label image-02"],"purpose":["Purpose Skin protectant"],"set_id":"c3be950b-28cf-47c2-9570-ebd46e43b1ba","spl_product_data_elements":["TCX Skincare Colloidal Oatmeal OATMEAL OATMEAL WATER GLYCERIN CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYL PALMITATE MINERAL OIL MEDIUM-CHAIN TRIGLYCERIDES CETYL ALCOHOL GLYCERYL 1-STEARATE DIMETHICONE, UNSPECIFIED PEG-40 MONOSTEARATE SODIUM HYDROXIDE PHENOXYETHANOL DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE OCTYLDODECANOL"],"version":"6","warnings":["Warnings • For external use only Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product: • Do not get into eyes • Stop use and ask doctor if condition worsens"],"when_using":["When using this product: • Do not get into eyes • Stop use and ask doctor if condition worsens"]}