{"active_ingredient":["Active ingredient Benzocaine 5%","Active ingredient Resorcinol 2%"],"dosage_and_administration":["Directions adults and children 12 years and older apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses. children under 12 years consult a doctor"],"dosage_and_administration_table":["<table><col width=\"319\"/><col width=\"319\"/><tbody><tr><td styleCode=\"Toprule Lrule Rrule \">adults and children 12 years and older   </td><td styleCode=\"Toprule Lrule Rrule \">apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses. </td></tr><tr><td styleCode=\"Toprule Lrule Rrule \">children under 12 years</td><td styleCode=\"Toprule Lrule Rrule \">consult a doctor</td></tr></tbody></table>"],"effective_time":"20241212","id":"c557751a-53ba-467c-8bf8-2ef3c03c07b7","inactive_ingredient":["Inactive ingredients Water, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Mineral Oil, Isopropyl Palmitate, Lactitol, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium HEDTA, Maltodextrin"],"indications_and_usage":["Use temporarily relieves itching"],"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":["M017"],"brand_name":["VAGISIL Anti-Itch Creme Regular Strength"],"generic_name":["BENZOCAINE AND RESORCINOL"],"is_original_packager":[true],"manufacturer_name":["Combe Incorporated"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["11509-5103-1"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["11509-5103"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["243587","849742"],"spl_id":["c557751a-53ba-467c-8bf8-2ef3c03c07b7"],"spl_set_id":["dd303ff8-0deb-4292-bfd8-5bda91f86d51"],"substance_name":["BENZOCAINE","RESORCINOL"],"unii":["U3RSY48JW5","YUL4LO94HK"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Vagisil Regular strength Anti Itch Crème Net Wt. 1 Oz (28 g) MEXICO Benzal Crema Vagisil Fórmula: Cada 100g contiene: Benzocaina 5g, Resorcinol 2g, Excipiente cbp 100 Auxiliar en el alivio al contacto de la comezón femenina, ayuando a prevenir una mayor irritación. Benzal Crema Vagisil auxiliar en aliviar al contacto la comezón, ardor, irritaciones y molestias menores del área externa que rodea la vagina. Contiene un anestésico que actúa para calmar la comezón, el ardor y la irritación leve. Indicaciones: Auxiliar en el tratamiento de comezón, ardor e irritación leve. Modo de E mpleo: Únicamente para USO EXTERNO Evite el contacto con los ojos. No se aplique en grandes áreas del cuerpo. Si las molestias persisten por más de 3 días o desaparecen y vuelven a aparecer en pocos días, o la condición empeora, suspenda su uso y consulte a su médico. En caso de ingestión accidental, busque ayuda médica inmediamente. Vía de A dministra ción : Tópica. Unicamente para USO EXTERNO VAGINAL. No se deje al alcance de los niños. Consérvese del tubo bien tapado. Consérvese a no más de 30°C. Dosis: Adultos y niñas mayores de 2 años. Aplique una capa en el área afectada no más de 3 ó 4 veces al día. Uso en Embarazo y Lactancia: No se use durante el embarazo o lactancia. Uso Pediátrico: No se use en niñas menores de 2 años, Contraindicaciones: Infecciones vaginales graves. Infecciones vaginales repetidas. Hipersensibilidad a los componentes de la fórmula. Si persisten las molestias por más 3 días, los síntomas no mejoran o empeoran, consulte a su médico. Reporte las sospechas de reacción adversa a correo: farmacovigilancia@cofepris.gob.mx PRINCIPAL DISPLAY PANEL Benzal Crema Vagisil Benzocaína / Resorcinol Crema 5%, 2% Con anestésico Calma la comezón Caja con tubo con 30g PRINCIPAL DISPLAY PANEL Vagisil Regular strength Anti Itch Crème Net Wt. 1 Oz (28 g) PRINCIPAL DISPLAY PANEL Benzal Crema Vagisil Benzocaína / Resorcinol Crema 5%, 2% Con anestésico Calma la comezón Caja con tubo con 30g"],"purpose":["Purpose External analgesic","Purpose External analgesic"],"set_id":"dd303ff8-0deb-4292-bfd8-5bda91f86d51","spl_product_data_elements":["VAGISIL Anti-Itch Creme Regular Strength Benzocaine and Resorcinol BENZOCAINE BENZOCAINE RESORCINOL RESORCINOL WATER CETYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 MONOSTEARATE MINERAL OIL ISOPROPYL PALMITATE LACTITOL ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE VITAMIN A PALMITATE CORN OIL CHOLECALCIFEROL LANOLIN ALCOHOLS METHYLPARABEN CARBOXYPOLYMETHYLENE ISOPROPYL MYRISTATE ISOPROPYL STEARATE SODIUM SULFITE TRISODIUM HEDTA MALTODEXTRIN"],"spl_unclassified_section":["VAGISIL Anti-Itch Creme Regular Strength Drug Facts"],"stop_use":["Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days Do not apply over large areas of the body"],"version":"4","warnings":["Warnings For external use only Avoid contact with eyes Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days Do not apply over large areas of the body Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."]}