{"active_ingredient":["Active ingredient Pramoxine HCL 1%"],"dosage_and_administration":["Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor"],"effective_time":"20240110","id":"86c0c7f3-4ba3-4ae2-8f3b-a618dc33eda0","inactive_ingredient":["Inactive ingredients Water, White Petrolatum, Glycerin, PEG-100 Stearate, Glyceryl Stearate SE, Stearic Acid, Copaifera Coriacea Resin Oil, Tetrahydrodiferuloylmethane, Cetyl Alcohol, Stearyl Alcohol, Phenoxyethanol, Vitamin E (Tocopheryl acetate), Xanthan Gum, Sodium Citrate, Disodium EDTA."],"indications_and_usage":["Use for the temporary relief of itching associated with minor skin irritations"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."],"openfda":{"application_number":["M015"],"brand_name":["Prosoria Anti-Itch Moisturizer"],"generic_name":["PRAMOXINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Nuvothera, Inc."],"package_ndc":["71573-120-11"],"product_ndc":["71573-120"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["1246075"],"spl_id":["86c0c7f3-4ba3-4ae2-8f3b-a618dc33eda0"],"spl_set_id":["3c4b9515-f435-4227-a347-d6508778426d"],"substance_name":["PRAMOXINE HYDROCHLORIDE"],"unii":["88AYB867L5"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label moisturizes relieves itching prosoriä anti-itch moisturizer Pramoxine Hydrochloride 1% external analgesic 3 FL OZ (90mL) Principal Display Panel - 90 mL Bottle Label"],"purpose":["Purpose External analgesic"],"questions":["Questions? Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon – Fri, 8am – 5pm CT."],"set_id":"3c4b9515-f435-4227-a347-d6508778426d","spl_product_data_elements":["Prosoria Anti-Itch Moisturizer Pramoxine Hydrochloride Pramoxine Hydrochloride Pramoxine Water Cetyl alcohol COPAIFERA OFFICINALIS RESIN Tetrahydrodiferuloylmethane Glyceryl Stearate SE PEG-100 STEARATE Phenoxyethanol Edetate Disodium Anhydrous SODIUM CITRATE, UNSPECIFIED FORM Stearic Acid Glycerin Stearyl Alcohol .ALPHA.-TOCOPHEROL ACETATE Xanthan Gum"],"spl_unclassified_section":["Drug Facts","Distributed by Nuvothera, Inc. Fort Worth, Texas 76104"],"stop_use":["Stop use and consult a doctor if the condition worsens symptoms last more than 7 days or clear up and occur again within a few days."],"version":"2","warnings":["Warnings For external use only When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and consult a doctor if the condition worsens 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 immediately."],"when_using":["When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water."]}