{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Keeps Minoxidil Topical Solution, 5% Minoxidil Solution WATER ALCOHOL PROPYLENE GLYCOL MINOXIDIL MINOXIDIL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Made in Israel Distributed by: Thirty Madison, Inc. New York, NY 10016"
      ],
      "active_ingredient": [
        "Active ingredient Minoxidil USP 5% w/v"
      ],
      "purpose": [
        "Purpose Hair regrowth treatment for men"
      ],
      "indications_and_usage": [
        "Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)"
      ],
      "warnings": [
        "Warnings For external use only. For use by men 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. 5% minoxidil topical solution 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 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. Results may occur at 2 months with twice a day 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 all men. 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 If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"
      ],
      "do_not_use": [
        "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. 5% minoxidil topical solution 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 and 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": [
        "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. Results may occur at 2 months with twice a day 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 all men."
      ],
      "stop_use": [
        "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"
      ],
      "pregnancy_or_breast_feeding": [
        "May be harmful if used when pregnant or breast-feeding."
      ],
      "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. (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. hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution store at controlled room temperature 20º to 25º C (68º to 77º F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients alcohol (28.86% v/v), propylene glycol, purified water"
      ],
      "questions": [
        "Questions? Call toll-free 1-866-923-4914"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton Carton"
      ],
      "set_id": "236d9984-d9a3-a87d-e063-6394a90a4958",
      "id": "3bce6383-1106-5096-e063-6294a90ae8ff",
      "effective_time": "20250807",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA217998"
        ],
        "brand_name": [
          "Keeps Minoxidil Topical Solution, 5%"
        ],
        "generic_name": [
          "MINOXIDIL SOLUTION"
        ],
        "manufacturer_name": [
          "Keeps (30 Madison)"
        ],
        "product_ndc": [
          "71713-102"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MINOXIDIL"
        ],
        "rxcui": [
          "311724"
        ],
        "spl_id": [
          "3bce6383-1106-5096-e063-6294a90ae8ff"
        ],
        "spl_set_id": [
          "236d9984-d9a3-a87d-e063-6394a90a4958"
        ],
        "package_ndc": [
          "71713-102-04",
          "71713-102-09"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175379",
          "N0000175564"
        ],
        "pharm_class_pe": [
          "Arteriolar Vasodilation [PE]"
        ],
        "pharm_class_epc": [
          "Arteriolar Vasodilator [EPC]"
        ],
        "unii": [
          "5965120SH1"
        ]
      }
    }
  ]
}