{"active_ingredient":["Active ingredients Colloidal Oatmeal 0.5%"],"dosage_and_administration":["Directions Apply as needed"],"effective_time":"20250304","id":"2f8a2c3d-48bc-c052-e063-6294a90a925b","inactive_ingredient":["Water, stearic acid, glycerin, c12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, glyceryl stearate SE, cetearyl alcohol, butyrospermum parkii (shea) butter, dimethicone, squalene, phenoxyethanol, caprylyl glycol. xanthan gum, myroxylon pereirae (balsam peru) oil, vanillin, allantoin, sodium hydroxide, tetrasodium EDTA, chrysanthemum parthenium (feverfew) extract, camellia sinensis leaf extract, glycyrrhiza glabra (licorice) root extract, ceramide NP, lavandula angustifolia (lavender) oil"],"indications_and_usage":["Uses Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, 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":["First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla"],"generic_name":["COLLOIDAL OATMEAL"],"is_original_packager":[true],"manufacturer_name":["The Procter & Gamble Manufacturing Company"],"nui":["N0000185371","N0000185375","N0000175629","N0000184306","M0000728","M0006342","M0016962","N0000185016"],"package_ndc":["69423-563-39","69423-563-56"],"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":["69423-563"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1654149"],"spl_id":["2f8a2c3d-48bc-c052-e063-6294a90a925b"],"spl_set_id":["f19b3056-063c-63ec-e053-2995a90a4614"],"substance_name":["OATMEAL"],"unii":["8PI54V663Y"],"upc":["0815517020645"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 14.0 oz (396.8 g) First Aid Beauty FAB Ultra Repair® Cream Intense Hydration Skin Protectant Colloidal Oatmeal Vanilla Natural Infusion FIrst Aid Beauty ® Net Wt. 14.0 oz (396.8 g) FAB"],"purpose":["Purpose Skin Protectant"],"questions":["Questions: 888-FAB-3063"],"set_id":"f19b3056-063c-63ec-e053-2995a90a4614","spl_product_data_elements":["First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla Colloidal Oatmeal LAVENDER OIL TANACETUM PARTHENIUM WHOLE CETOSTEARYL ALCOHOL SQUALANE DIMETHICONE EDETATE DISODIUM GLYCERYL STEARATE SE ALKYL (C12-15) BENZOATE GREEN TEA LEAF CAPRYLYL GLYCOL SODIUM HYDROXIDE PHENOXYETHANOL SHEA BUTTER GLYCYRRHIZA GLABRA WATER GLYCERIN OATMEAL OATMEAL ALLANTOIN GLYCERYL MONOSTEARATE MEDIUM-CHAIN TRIGLYCERIDES STEARIC ACID XANTHAN GUM BALSAM PERU OIL CERAMIDE NP VANILLIN"],"spl_unclassified_section":["Drug Facts","MADE IN USA FIRST AID BEAUTY LTD NEWTON, MA 02458 WWW.FIRSTAIDBEAUTY.COM"],"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"],"version":"3","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. Do not get into eyes. 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":["Do not get into eyes."]}