{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Prestige Chloroxylenol WATER LAURAMINE OXIDE EDETATE SODIUM ISOPROPYL ALCOHOL POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) CITRIC ACID MONOHYDRATE SODIUM C14-16 OLEFIN SULFONATE SODIUM LAURETH SULFATE CHLOROXYLENOL CHLOROXYLENOL white, opaque liquid"
      ],
      "active_ingredient": [
        "Active Ingredient Chloroxylenol 1% w/w"
      ],
      "purpose": [
        "Purpose Skin Antimicrobial"
      ],
      "indications_and_usage": [
        "Use reduces amount of bacteria on hands"
      ],
      "warnings": [
        "Warnings For external use only. Do not use in eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician. Not for use on children under 6 months of age. For institutional and professional use only."
      ],
      "keep_out_of_reach_of_children": [
        "Not for use on children under 6 months of age. For institutional and professional use only."
      ],
      "dosage_and_administration": [
        "Directions Wet hands and forearms. Apply a small amount (5 mL) or palmful to hands and forearms. Scrub thoroughly for at least fifteen seconds. Rinse completely and dry."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid"
      ],
      "package_label_principal_display_panel": [
        "Product Label - 1 Gallon ShortNeck Bottle"
      ],
      "set_id": "2e4bb97c-9c16-43d1-aea3-54723c7afc45",
      "id": "14308390-5ca6-80b4-e063-6294a90a02ee",
      "effective_time": "20240321",
      "version": "4",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Prestige"
        ],
        "generic_name": [
          "CHLOROXYLENOL"
        ],
        "manufacturer_name": [
          "Sunburst Chemicals, Inc."
        ],
        "product_ndc": [
          "63621-335"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CHLOROXYLENOL"
        ],
        "rxcui": [
          "413257"
        ],
        "spl_id": [
          "14308390-5ca6-80b4-e063-6294a90a02ee"
        ],
        "spl_set_id": [
          "2e4bb97c-9c16-43d1-aea3-54723c7afc45"
        ],
        "package_ndc": [
          "63621-335-14"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "0F32U78V2Q"
        ]
      }
    }
  ]
}