{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Anti Dandruff Ketoconazole KETOCONAZOLE KETOCONAZOLE AQUA SODIUM LAURETH SULFATE COCAMIDE DEA SODIUM CHLORIDE COCAMIDOPROPYL BETAINE AMMONIUM LAURYL SULFATE POLYQUATERNIUM-10 (1000 MPA.S AT 2%) FRAGRANCE FLORAL ORC0902236 PHENOXYETHANOL PEG-7 GLYCERYL COCOATE AMINOPROPYL DIMETHICONE (1000 MPA.S) HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE C12-13 PARETH-3 LACTIC ACID CITRIC ACID C11-15 PARETH-9 TRIDECETH-12 SODIUM BENZOATE"
      ],
      "active_ingredient": [
        "Active ingredient Ketoconazole 1% Purpose Anti-dandruff"
      ],
      "purpose": [
        "Helps control flaking and itching associated with dandruff"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help orcontact a Poison Control Center right away."
      ],
      "warnings": [
        "Stop use and ask a doctor if rash occurs condition worsens or does not improve after regular use as directed aIf pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. If swallowed, get medical help or contacta Poison Control Centerright away."
      ],
      "dosage_and_administration": [
        "Repeat.use every 3-4 days forup to 8 weeks or as directedby a doctor."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aqua, Sodium Laureth Sulfate, Cocamide DEA, SodiumChloride, Cocamidopropyl Betaine, Ammonium LaurylSulfate, Polyquaternium-10, Fragrance, Phenoxyethanol,PEG-7 Glyceryl Cocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl Guar Hydroxypropyltrimonium Chloride,C12-13 Pareth-3, Lactate, Citric Acid, C11-15 Pareth-9,Trideceth-12, Sodium Benzoate."
      ],
      "indications_and_usage": [
        "Directions adults and children 12 years and older: wet hairthoroughly,apply shampoo, generously lather, rinsethoroughly. Repeat.use every 3-4 days for up to 8 weeks or as directedby a doctor. Then use only as needed to controldandruff."
      ],
      "package_label_principal_display_panel": [
        "packeg labeling 标签"
      ],
      "set_id": "599f2cce-0c27-d425-e063-6394a90a1565",
      "id": "599f2cce-0c28-d425-e063-6394a90a1565",
      "effective_time": "20260822",
      "version": "1",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Anti Dandruff"
        ],
        "generic_name": [
          "KETOCONAZOLE"
        ],
        "manufacturer_name": [
          "Guangzhou ChuanMa International Trading Co.,Ltd."
        ],
        "product_ndc": [
          "85593-121"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "KETOCONAZOLE"
        ],
        "rxcui": [
          "240812"
        ],
        "spl_id": [
          "599f2cce-0c28-d425-e063-6394a90a1565"
        ],
        "spl_set_id": [
          "599f2cce-0c27-d425-e063-6394a90a1565"
        ],
        "package_ndc": [
          "85593-121-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175487",
          "M0002083",
          "N0000182141",
          "N0000190115",
          "N0000185503"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 3A5 Inhibitors [MoA]",
          "P-Glycoprotein Inhibitors [MoA]"
        ],
        "unii": [
          "R9400W927I"
        ]
      }
    }
  ]
}