{
  "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": [
        "Keystone Benzalkonium chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER COCAMINE OXIDE HEXYLENE GLYCOL POLYETHYLENE GLYCOL 8000 GLYCERIN HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE PHENOXYETHANOL MYRISTIC DIISOPROPANOLAMIDE MYRISTAMINE OXIDE METHYL GLUCETH-20 GLYCERYL MONO- AND DICAPRYLOCAPRATE ALCOHOL PEG-12 DIMETHICONE (300 CST) ANHYDROUS CITRIC ACID POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) POTASSIUM HYDROXIDE FD&C BLUE NO. 1"
      ],
      "active_ingredient": [
        "Active ingredient Benzalkonium Chloride, 0.5%"
      ],
      "purpose": [
        "Purpose Antiseptic handwash"
      ],
      "indications_and_usage": [
        "Uses for handwashing to decrease bacteria on the skin"
      ],
      "warnings": [
        "Warnings For external use only Do not use in eyes When using the product if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop Stop use and ask a doctor if skin irritation or redness occurs 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 eyes"
      ],
      "when_using": [
        "When using the product if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop"
      ],
      "ask_doctor": [
        "Stop use and ask a doctor if skin irritation or redness occurs 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 and apply product scrub hands and forearms rinse thoroughly and dry"
      ],
      "references": [
        "Other information for additional information, see Safety Data Sheet (SDS) for emergency medical information in USA and Canada, call 1 800 328 0026"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, hydroxyethylcellulose, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, myristamide DIPA, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, citric acid, polyquatemium-7, fragrance, potassium hydroxide, blue 1"
      ],
      "questions": [
        "Questions? call 1-866-781-8787"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel and representative label KEYSTONE Sysco ADVANCED ANTIBACTERIAL LIQUID HAND SOAP Active Ingredient: 0.5% Benzalkonium Chloride Net Contents 750 mL (25 US fl oz) 6000234 Sysco 5287436 6101969 ECOLAB® This product may be patented: www.ecolab.com/patents For SDS information visit: www.cleanwithkeystone.com Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326) © 2018 Ecolab USA Inc. · All rights reserved Made in U.S.A. www.ecolab.com · 773734/5400/0818 representative label"
      ],
      "set_id": "14ba88a3-af32-4191-afed-cdcc7eb8ad6a",
      "id": "912823fb-4be3-43a4-a634-0d06c6ec86b8",
      "effective_time": "20240805",
      "version": "2",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Keystone"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Ecolab Inc."
        ],
        "product_ndc": [
          "47593-594"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "rxcui": [
          "1731737"
        ],
        "spl_id": [
          "912823fb-4be3-43a4-a634-0d06c6ec86b8"
        ],
        "spl_set_id": [
          "14ba88a3-af32-4191-afed-cdcc7eb8ad6a"
        ],
        "package_ndc": [
          "47593-594-11"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F5UM2KM3W7"
        ]
      }
    }
  ]
}