{
  "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 PHENOXYETHANOL PEG-7 GLYCERYL COCOATE HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE C12-13 ALKYL LACTATE CITRIC ACID COCAMIDOPROPYL BETAINE C11-15 PARETH-9 AMINOPROPYL DIMETHICONE (2000 MPA.S) COCAMIDE DEA SODIUM BENZOATE TRIDECETH-12 SODIUM CHLORIDE AMMONIUM LAURYL SULFATE AQUA SODIUM LAURETH-2 SULFATE KETOCONAZOLE KETOCONAZOLE"
      ],
      "active_ingredient": [
        "ketoconazole 1%"
      ],
      "purpose": [
        "Anti Dandruff"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children"
      ],
      "warnings": [
        "For external use only"
      ],
      "indications_and_usage": [
        "For best results, follow these stepscarefully:1.Wet hair and scalp thoroughly with lukewarm water. 2.Apply a sufficient amount of shampoo to generate a rich lather. 3.Gently massage the lather into your scalp and hair.4.Leavethe latheron the scalp for3-5minutes. This contact time is crucialforthemedication to work effectively.5.Rinse thoroughly with water."
      ],
      "dosage_and_administration": [
        "Use every 3-4 days for up to 8 weeks. Afterthat, use only as needed to control dandruff."
      ],
      "inactive_ingredient": [
        "Aqua, Sodium Laureth Sulfate, Cocamide DEA,Sodium Chloride, Cocamidopropyl Betaine,Ammonium LaurylSulfate, Ketoconazole,Fragrance, Phenoxyethanol, PEG-7 GlycerylCocoate, Bis-Aminopropyl Dimethicone,Hydroxypropyl Guar HydroxypropyltrimoniumChloride, C12-13 Pareth Lactate, CitricAcid, C11-15 Pareth-9, Trideceth-12, Sodium Benzoate."
      ],
      "package_label_principal_display_panel": [
        "labeling"
      ],
      "set_id": "4cfe234c-49c0-18e8-e063-6294a90a0b1d",
      "id": "55a48fc6-194b-66ea-e063-6294a90a3501",
      "effective_time": "20260702",
      "version": "2",
      "openfda": {
        "application_number": [
          "M005"
        ],
        "brand_name": [
          "Anti Dandruff"
        ],
        "generic_name": [
          "KETOCONAZOLE"
        ],
        "manufacturer_name": [
          "Guangzhou ChuanMa International Trading Co.,Ltd."
        ],
        "product_ndc": [
          "85593-033"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "KETOCONAZOLE"
        ],
        "rxcui": [
          "240812"
        ],
        "spl_id": [
          "55a48fc6-194b-66ea-e063-6294a90a3501"
        ],
        "spl_set_id": [
          "4cfe234c-49c0-18e8-e063-6294a90a0b1d"
        ],
        "package_ndc": [
          "85593-033-01"
        ],
        "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"
        ]
      }
    }
  ]
}