{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Sterillium Foam Alcohol BIS-PEG/PPG-20/20 DIMETHICONE ISOPROPYL ALCOHOL MYRISTYL ALCOHOL WATER CYCLOMETHICONE GLYCERIN 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": [
        "Do not use in or near the eyes or on mucous membranes. In case of contact, rinse thoughly with water."
      ],
      "stop_use": [
        "Stop use and ask a doctor if irritation and redness develop conditions 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 Apply to clean, dry hands, covering entire surface, including nails Rub until dry Supervise children in the use of this product"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Bis-PEG/PPG-20/20 Dimethicone, Cyclomethicone, Glycerin, Isopropyl Alcohol, Myristyl Alcohol, Water."
      ],
      "recent_major_changes": [
        "Uses • To decrease bacteria on the skin. • Recommended for repeated use."
      ],
      "package_label_principal_display_panel": [
        "Sterillium foam Healthcare Personnel Hand Antiseptic Kills > 99.999% of germs in 15 seconds without water. Dermatologically tested. Fragrance Free Hand Antiseptic Foam 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 65616-006-03 500 mL 16.91 fl. oz container label container labelF carton 4 label"
      ],
      "set_id": "93680cd8-609f-48f2-e053-2995a90aa355",
      "id": "4d2a68b7-91b6-27e1-e063-6394a90a07f7",
      "effective_time": "20260316",
      "version": "9",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Sterillium Foam"
        ],
        "generic_name": [
          "ALCOHOL"
        ],
        "manufacturer_name": [
          "BODE Chemie GmbH"
        ],
        "product_ndc": [
          "65616-006"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ALCOHOL"
        ],
        "rxcui": [
          "2200822"
        ],
        "spl_id": [
          "4d2a68b7-91b6-27e1-e063-6394a90a07f7"
        ],
        "spl_set_id": [
          "93680cd8-609f-48f2-e053-2995a90aa355"
        ],
        "package_ndc": [
          "65616-006-03",
          "65616-006-06",
          "65616-006-11",
          "65616-006-12",
          "65616-006-13",
          "65616-006-14",
          "65616-006-15",
          "65616-006-16",
          "65616-006-17",
          "65616-006-18",
          "65616-006-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "4031678089529",
          "4031678087273"
        ],
        "unii": [
          "3K9958V90M"
        ]
      }
    }
  ]
}