{"active_ingredient":["Drug Facts Active Ingredient Colloidal Oatmeal 2.0%"],"dosage_and_administration":["Directions Adults and children 5 years and over apply gently to the affected area as needed. Not recommended for face."],"effective_time":"20251212","id":"45c89ca7-3354-d315-e063-6394a90ac647","inactive_ingredient":["Inactive Ingredients Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water"],"indications_and_usage":["Uses 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":["ECZEMA"],"generic_name":["COLLOIDAL OATMEAL"],"is_original_packager":[true],"manufacturer_name":["Smith Amish, LLC"],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","N0000185016"],"package_ndc":["72609-704-04"],"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":["72609-704"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["45c89ca7-3354-d315-e063-6394a90ac647"],"spl_set_id":["20c4bc16-ba20-47ec-e063-6394a90a8b4e"],"substance_name":["OATMEAL"],"unii":["8PI54V663Y"]},"other_safety_information":["Other information Protect from excessive heat Store at 20-25 o C (68-77F)"],"package_label_principal_display_panel":["Label Smith Amish Eczema Cream (72609-704-02) Deep Moisturizing Cream for sensitive, distressed, dry, scaly skin Clean Fresh Scent Easily Absorbed and Non-Greasy Net wt. 2oz (59g) labels"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Skin Protectant"],"questions":["Questions? Call (866) 419-3567 Monday through Friday 8:00am - 2:00pm ET"],"set_id":"20c4bc16-ba20-47ec-e063-6394a90a8b4e","spl_product_data_elements":["ECZEMA COLLOIDAL OATMEAL ALMOND OIL OATMEAL OATMEAL JOJOBA OIL GLYCERYL MONOSTEARATE PEPPERMINT OIL .ALPHA.-TOCOPHEROL ARNICA MONTANA WHOLE CETYL PALMITATE SODIUM CITRATE STEARIC ACID TEA TREE OIL WATER GLYCERIN PHENOXYETHANOL PANTHENOL"],"spl_unclassified_section":["Tamper evident: Do not use if safety seal under cap is broken or missing. Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634"],"stop_use":["If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,, discontinue use of this product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly."],"version":"5","warnings":["Warnings For external use only When using this product do not get into eyes If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,, discontinue use of this product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly. If pregnant or breast-feeding, ask a health professional before use."]}