{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Miconazole 7 Miconazole Nitrate BENZOIC ACID BUTYLATED HYDROXYANISOLE MINERAL OIL APRICOT KERNEL OIL PEG-6 ESTERS PEGOXOL 7 STEARATE WATER MICONAZOLE NITRATE MICONAZOLE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: H2-Pharma, LLC Montgomery, AL 36117"
      ],
      "active_ingredient": [
        "Active ingredient Miconazole nitrate USP, 2% (100 mg in each applicator)"
      ],
      "purpose": [
        "Purpose Vaginal antifungal"
      ],
      "indications_and_usage": [
        "Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection"
      ],
      "warnings": [
        "Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor. Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. When using this product do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use if you have never had a vaginal yeast infection diagnosed by a doctor."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur."
      ],
      "when_using": [
        "When using this product do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product"
      ],
      "stop_use": [
        "Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use do not use if foil seal on tube opening is broken or missing do not purchase if carton is open store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F) before using any medication, read all label directions. Keep carton, it contains important information."
      ],
      "inactive_ingredient": [
        "Inactive ingredients benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water"
      ],
      "questions": [
        "Questions? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL pdp"
      ],
      "set_id": "0c055a0d-1031-e7d5-e063-6294a90a17e2",
      "id": "2d3fbb35-987f-7d36-e063-6394a90a1acd",
      "effective_time": "20250203",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA074164"
        ],
        "brand_name": [
          "Miconazole 7"
        ],
        "generic_name": [
          "MICONAZOLE NITRATE"
        ],
        "manufacturer_name": [
          "NuCare Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "68071-3544"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "VAGINAL"
        ],
        "substance_name": [
          "MICONAZOLE NITRATE"
        ],
        "rxcui": [
          "998540"
        ],
        "spl_id": [
          "2d3fbb35-987f-7d36-e063-6394a90a1acd"
        ],
        "spl_set_id": [
          "0c055a0d-1031-e7d5-e063-6294a90a17e2"
        ],
        "package_ndc": [
          "68071-3544-7"
        ],
        "original_packager_product_ndc": [
          "61269-730"
        ],
        "upc": [
          "0368071354478"
        ],
        "unii": [
          "VW4H1CYW1K"
        ]
      }
    }
  ]
}