{
  "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,
      "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 PHENOXYETHANOL PEG-7 GLYCERYL COCOATE HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE CITRIC ACID C11-15 PARETH-9 TRIDECETH-12 SODIUM BENZOATE C12-13 PARETH-9 AMINOPROPYL DIMETHICONE (1000 MPA.S)"
      ],
      "active_ingredient": [
        "Active ingredient Purpose Ketoconazole 1% w/w....Anti-dandruff shampoo"
      ],
      "purpose": [
        "Relieves ItchingControls FlakingScalp Clarifying Seborrheic Dermatitis Care"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children"
      ],
      "warnings": [
        "For external use only. Avoid contact witheyes. Ifcontact occurs, rinse thoroughlywithwater."
      ],
      "dosage_and_administration": [
        "Use every 3-4 days for up to 8 weeks. Afterthat, use only asneeded to control dandruff."
      ],
      "indications_and_usage": [
        "For best results, follow these steps carefully:lukewarm water. 1.Wet hair and scalp thoroughly with 2.Applya sufficient amount of shampooto generate a rich lather.3.Gently massage the lather into your scalp and hair. 4.Leave the lather on the scalp for 3-5medication to work effectively.5.Rinse thoroughly with water. minutes. This contact time is crucialfor the"
      ],
      "inactive_ingredient": [
        "Aqua, Sodium Laureth Sulfate, CocamideDEA, Sodium Chloride, CocamidopropylBetaine, Ammonium Lauryl Sulfate,Fragrance, Phenoxyethanol, PEG-7 GlycerylCocoate,Aminopropyl Dimethicone,Hydroxypropyl GuarHydroxypropyltrimonium Chloride, C12-13Pareth Lactate, CitricAcid, C11-15 Pareth-9,Trideceth-12, Sodium Benzoate."
      ],
      "package_label_principal_display_panel": [
        "85593-128 information"
      ],
      "set_id": "5ac93feb-eb6d-7563-e063-6294a90ad2e0",
      "id": "5ac93feb-eb6e-7563-e063-6294a90ad2e0",
      "effective_time": "20260905",
      "version": "1",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "ANTI-DANDRUFF"
        ],
        "generic_name": [
          "KETOCONAZOLE"
        ],
        "manufacturer_name": [
          "Guangzhou ChuanMa International Trading Co.,Ltd."
        ],
        "product_ndc": [
          "85593-128"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "KETOCONAZOLE"
        ],
        "rxcui": [
          "240812"
        ],
        "spl_id": [
          "5ac93feb-eb6e-7563-e063-6294a90ad2e0"
        ],
        "spl_set_id": [
          "5ac93feb-eb6d-7563-e063-6294a90ad2e0"
        ],
        "package_ndc": [
          "85593-128-01"
        ],
        "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"
        ]
      }
    }
  ]
}