{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sterillium comfort alcohol ISOPROPYL ALCOHOL GLYCERIN MYRISTYL ALCOHOL CYCLOMETHICONE CARBOMER INTERPOLYMER TYPE A (55000 CPS) EDETOL POVIDONE K90 WATER ISOHEXADECANE LEVOMENOL ALCOHOL ALCOHOL"
      ],
      "active_ingredient": [
        "Active ingredient Ethyl Alcohol 85 % v/v"
      ],
      "purpose": [
        "Purpose Antiseptic"
      ],
      "indications_and_usage": [
        "Uses • To decrease bacteria on the skin. • Recommended for repeated use."
      ],
      "warnings": [
        "Warnings For external use only. Flammable, keep away from fire or flame. Do not use in or near the eyes or on mucous membranes. In case of contact, rinse thoroughly with water. Stop use and ask a doctor if • irritation and redness develop • 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."
      ],
      "do_not_use": [
        "Do not use in or near the eyes or on mucous membranes. In case of contact, rinse thoroughly with water."
      ],
      "stop_use": [
        "Stop use and ask a doctor if • irritation and redness develop • 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 • Wet hands thoroughly with product and allow to dry without wiping • Supervise children in the use of this product"
      ],
      "inactive_ingredient": [
        "Inactive ingredients acrylates/C 10-30 alkyl acrylate crosspolymer, bisabolol, cyclomethicone, glycerin, isohexadecane, isopropyl alcohol, myristyl alcohol, PVP, tetrahydroxypropyl ethylenediamine, water"
      ],
      "package_label_principal_display_panel": [
        "Sterillium comfort gel Healthcare personnel Hand Rub Kills > 99.999% of germs in 15 seconds without water. Boosts skin moisture level. Leaves hands feeling soft and healthy. Dermatologically tested. Hand Antiseptic Gel 85 % v/v ethyl alcohol with moisturizers To decrease bacteria on the skin. Recommended for repeated use. Read drug facts panel before use. Designed in Germany. Made in USA. Lot: Use by: BODE NDC 65616-010-09 475 mL 16.06 fl. oz container labelfgel container labelBgel case label4"
      ],
      "set_id": "2d48dab8-f70a-a2b5-e063-6294a90a1456",
      "id": "4cc0e8b6-8640-d9a6-e063-6294a90a9caf",
      "effective_time": "20260316",
      "version": "2",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Sterillium comfort"
        ],
        "generic_name": [
          "ALCOHOL"
        ],
        "manufacturer_name": [
          "BODE Chemie GmbH"
        ],
        "product_ndc": [
          "65616-010"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ALCOHOL"
        ],
        "rxcui": [
          "1041851"
        ],
        "spl_id": [
          "4cc0e8b6-8640-d9a6-e063-6294a90a9caf"
        ],
        "spl_set_id": [
          "2d48dab8-f70a-a2b5-e063-6294a90a1456"
        ],
        "package_ndc": [
          "65616-010-09",
          "65616-010-20",
          "65616-010-21",
          "65616-010-22",
          "65616-010-07",
          "65616-010-17",
          "65616-010-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "4031678087433"
        ],
        "unii": [
          "3K9958V90M"
        ]
      }
    }
  ]
}