{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "ElixirTripleGuard Triple Antibiotic Miconazole Nitrate cream CAPRYLIC/CAPRIC TRIGLYCERIDE CETEARETH-20 CETEARYL ALCOHOL DIMETHICONE EDETATE DISODIUM GLYCERYL STEARATE IMIDAZOLIDINYL UREA PEG-100 STEARATE PEG-40 CASTOR OIL PETROLATUM PROPYLENE GLYCOL SODIUM CETEARYL SULFATE STEARIC ACID WATER XANTHAN GUM MICONAZOLE NITRATE MICONAZOLE"
      ],
      "active_ingredient": [
        "Active Ingredient (in each gram) Miconazole Nitrate 2%w/w"
      ],
      "purpose": [
        "Purpose Antifungal"
      ],
      "indications_and_usage": [
        "Uses Uses • For the treatment and prevention of most: • Athlete’s foot • Jock itch • Ringworm • Relieves itching, scaling, cracking, and discomfort associated with these conditions"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "do_not_use": [
        "Do not use on children under 2 years of age unless directed by a doctor"
      ],
      "when_using": [
        "When using this product Avoid contact with eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if • condition persists or gets worse • a rash or other allergic reaction develops"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions"
      ],
      "dosage_and_administration": [
        "Directions Clean the affected area and dry thoroughly • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product. For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily. For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional. For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional. This product is not effective on the scalp or nails."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum"
      ],
      "spl_unclassified_section": [
        "Other information • Store between 15-30°C (59-86°F)"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL Elixir Elixir MycoTender Miconazole Nitrate Antifungal Cream With 2% Micronazole Nitrate CURSE JOCK ITCH & RING WORM SOOTHES AND PROMOTES HEALING 4 Oz. (113) g Tube Lable.jpg"
      ],
      "set_id": "0482ce9f-c98a-4f37-8b37-6df1738b6da3",
      "id": "48749d03-2194-b2d4-e063-6394a90a731f",
      "effective_time": "20260115",
      "version": "1",
      "openfda": {
        "application_number": [
          "M005"
        ],
        "brand_name": [
          "ElixirTripleGuard Triple Antibiotic"
        ],
        "generic_name": [
          "MICONAZOLE NITRATE CREAM"
        ],
        "manufacturer_name": [
          "ELIXIR HEALTHCARE USA, LLC."
        ],
        "product_ndc": [
          "84546-0007"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MICONAZOLE NITRATE"
        ],
        "rxcui": [
          "998483"
        ],
        "spl_id": [
          "48749d03-2194-b2d4-e063-6394a90a731f"
        ],
        "spl_set_id": [
          "0482ce9f-c98a-4f37-8b37-6df1738b6da3"
        ],
        "package_ndc": [
          "84546-0007-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "VW4H1CYW1K"
        ]
      }
    }
  ]
}