{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Minoxidil Topical Solution 2% Minoxidil Topical Solution 2% ALCOHOL WATER PROPYLENE GLYCOL MINOXIDIL MINOXIDIL" ], "active_ingredient": [ "Active ingredient Minoxidil USP 2% w/v" ], "purpose": [ "Purpose Hair regrowth treatment" ], "indications_and_usage": [ "Use to regrow hair on the scalp" ], "warnings": [ "Warnings For external use only. Flammable: Keep away from fire or flame Do not use if your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you you have no family history of hair loss your hair loss is sudden and/or patchy your hair loss is associated with childbirth you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp 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 it takes time to regrow hair. You may need to use this product 2 times a day 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 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 May be harmful if used when pregnant or breast-feeding." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "dosage_and_administration": [ "Directions apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again Other information see hair loss pictures on side of this carton before use, read all information on carton and enclosed leaflet keep the carton. It contains important information. In clinical studies of mostly white women aged 18 to 45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth). store at controlled room temperature 20º to 25º C (68º to 77º F)" ], "other_safety_information": [ "Other information see hair loss pictures on side of this carton before use, read all information on carton and enclosed leaflet keep the carton. It contains important information. In clinical studies of mostly white women aged 18 to 45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth). store at controlled room temperature 20º to 25º C (68º to 77º F)" ], "inactive_ingredient": [ "Inactive ingredients alcohol (59.85% v/v), propylene glycol, purified water Questions? Call toll-free 1-866-923-4914" ], "questions": [ "Questions? Call toll-free 1-866-923-4914" ], "spl_unclassified_section": [ "Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Made in Israel" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Carton" ], "set_id": "15d7cdd7-6d37-477c-bce7-a459ea960a53", "id": "4c3823f2-ce4b-afea-e063-6294a90a03c0", "effective_time": "20260304", "version": "4", "openfda": { "application_number": [ "ANDA218175" ], "brand_name": [ "Minoxidil Topical Solution 2%" ], "generic_name": [ "MINOXIDIL TOPICAL SOLUTION 2%" ], "manufacturer_name": [ "SUN PHARMACEUTICAL INDUSTRIES, INC." ], "product_ndc": [ "51672-2152" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "MINOXIDIL" ], "rxcui": [ "311723" ], "spl_id": [ "4c3823f2-ce4b-afea-e063-6294a90a03c0" ], "spl_set_id": [ "15d7cdd7-6d37-477c-bce7-a459ea960a53" ], "package_ndc": [ "51672-2152-4", "51672-2152-9" ], "is_original_packager": [ true ], "nui": [ "N0000175379", "N0000175564" ], "pharm_class_pe": [ "Arteriolar Vasodilation [PE]" ], "pharm_class_epc": [ "Arteriolar Vasodilator [EPC]" ], "unii": [ "5965120SH1" ] } } ] }