{"active_ingredient":["Active Ingredients Minoxidil 5% w/v"],"dosage_and_administration":["Directions Apply one mL 2 times daily directly onto the scalp in the hair loss area. Using more or more often will not improve results. Continued use is necessary or hair loss will resume."],"effective_time":"20251203","id":"450fe25c-0ed3-eb99-e063-6394a90a6f32","inactive_ingredient":["Inactive Ingredients Alcohol, Propylene Glycol, Purified water"],"indications_and_usage":["Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)."],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately. (1-800-222-1222)"],"openfda":{"application_number":["ANDA075598"],"brand_name":["Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men"],"generic_name":["MINOXIDIL"],"manufacturer_name":["Loesch Laboratory Consultant, INC."],"nui":["N0000175379","N0000175564"],"original_packager_product_ndc":["63981-798"],"package_ndc":["25280-006-42"],"pharm_class_epc":["Arteriolar Vasodilator [EPC]"],"pharm_class_pe":["Arteriolar Vasodilation [PE]"],"product_ndc":["25280-006"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["311724"],"spl_id":["450fe25c-0ed3-eb99-e063-6394a90a6f32"],"spl_set_id":["d158d3af-6850-48c0-8355-9df0637684cc"],"substance_name":["MINOXIDIL"],"unii":["5965120SH1"]},"other_safety_information":["Other information See hair loss picture on the side of this carton. Before use, read all information on carton and printed insert. Keep the carton. It contains important information. Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution 5%. In clinical studies with mostly caucasian men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% for men provided more hair growth than Minoxidil Topical Solution 2%."],"package_label_principal_display_panel":["Carton"],"purpose":["Purpose Hair Regrowth Treatment For Men"],"questions":["Questions or Comments? 1-800-237-7157"],"recent_major_changes":[""],"set_id":"d158d3af-6850-48c0-8355-9df0637684cc","spl_product_data_elements":["Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men minoxidil MINOXIDIL MINOXIDIL WATER PROPYLENE GLYCOL ALCOHOL"],"statement_of_identity":["Drug Facts"],"version":"4","warnings":["Warnings For external use only. Flammable: Keep away from fire or flame.","Do not use if You are a woman Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Solution 5% is not intended for frontal baldness or receding hairline. You have no family history of hair loss. Your hair loss is sudden and/or patchy. You do not know the reason for your hair loss. You are under 18 years of age. Do not use on babies or children. Your scalp is red, inflamed, infected, irritated, or painful. You use other medicines on the scalp.","ASK DOCTOR Ask a doctor before use if you have heart disease.","When using this product Do not apply on other parts of the body. Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. Some people have experienced changes in hair color and/or texture. Results may occur at 2 months with twice daily usage. For some men, you may need to use this product for at least 4 months before you see results. The amount of hair regrowth is different for each person. This product will not work for everyone.","Stop use and ask a doctor if you have Chest pain, rapid heartbeat, faintness, or dizziness occurs. Sudden, unexplained weight gain occurs. Your hands or feet swell. Scalp irritation or redness occurs. Unwanted facial hair growth occurs. You do not see hair regrowth in 4 months.","Pregnancy or breast feeding ​May be harmful if used when pregnant or breast-feeding."]}