{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Byotrol Hand Sanitizer BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM WATER CETRIMONIUM CHLORIDE LAURTRIMONIUM CHLORIDE GLYCERETH-17 COCOATE DIHYDROXYETHYL COCAMINE OXIDE POLIHEXANIDE CAPRYLYL GLUCOSIDE C12-15 PARETH-7 CITRIC ACID MONOHYDRATE DIMETHICONE"
      ],
      "active_ingredient": [
        "Active ingredient Benzalkonium Chloride 0.13%"
      ],
      "purpose": [
        "Purpose Antimicrobial"
      ],
      "indications_and_usage": [
        "Uses For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use."
      ],
      "warnings": [
        "Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product avoid contact with eyes. In case of eye contact, flush eyes with water."
      ],
      "stop_use": [
        "Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Pump a small amount of foam onto hands. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry."
      ],
      "inactive_ingredient": [
        "Inactive ingredients: Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric Acid."
      ],
      "questions": [
        "Questions? 1-866-443-4509"
      ],
      "package_label_principal_display_panel": [
        "byotrol ANTIBACTERIAL FOAMING HAND SANITIZER ALCOHOL FREE KILLS GERMS POWERFUL LONG LASTING GENTLE Net Contents: 16.9 FL OZ (500mL) container label"
      ],
      "set_id": "09edbc17-c443-4b0d-9c28-c4b8233c4d1a",
      "id": "ef6a1c09-8491-4a08-bedc-a67ce00d9e23",
      "effective_time": "20171214",
      "version": "6",
      "openfda": {
        "application_number": [
          "part333A"
        ],
        "brand_name": [
          "Byotrol Hand Sanitizer"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Advanced Hygienics LLC"
        ],
        "product_ndc": [
          "63002-002"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "rxcui": [
          "1020365"
        ],
        "spl_id": [
          "ef6a1c09-8491-4a08-bedc-a67ce00d9e23"
        ],
        "spl_set_id": [
          "09edbc17-c443-4b0d-9c28-c4b8233c4d1a"
        ],
        "package_ndc": [
          "63002-002-99",
          "63002-002-50",
          "63002-002-12",
          "63002-002-75"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F5UM2KM3W7"
        ]
      }
    }
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}