{
  "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": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Saniclean Benzalkonium chloride EDETATE DISODIUM BENZYL SALICYLATE COUMARIN GERANIOL .ALPHA.-AMYLCINNAMALDEHYDE FD&C YELLOW NO. 5 WATER LAURAMINE OXIDE PEG-7 GLYCERYL COCOATE ANHYDROUS CITRIC ACID GLYCERIN BENZALKONIUM CHLORIDE BENZALKONIUM BUTYLPHENYL METHYLPROPIONAL LINALOOL, (+/-)- FD&C BLUE NO. 1"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other Information Store at room temperature. Do not use if you have ever had an allergic reaction to this product or any of its ingredients",
        "LOT EXP: Simoniz Saniclean, LLC 299 Dividend Road Rocky Hill, CT 06067 1-800-227-5536"
      ],
      "active_ingredient": [
        "Active ingredient Benzalkonium chloride 0.13%"
      ],
      "purpose": [
        "Purpose Antimicrobial"
      ],
      "indications_and_usage": [
        "Uses For handwashing to decrease bateria on skin."
      ],
      "warnings": [
        "Warnings For external use only. Do not use On infants under 5 months of age. When using this product Avoid contact with eyes. In case of eye contact, flush with water for 15 minutes. Stop use and ask a doctor if Irritation or redness develops. Keep out of reach of children. If ingested get medical help or contact a poison control right away."
      ],
      "do_not_use": [
        "Do not use On infants under 5 months of age."
      ],
      "when_using": [
        "When using this product Avoid contact with eyes. In case of eye contact, flush with water for 15 minutes."
      ],
      "stop_use": [
        "Stop use and ask a doctor if Irritation or redness develops."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If ingested get medical help or contact a poison control right away."
      ],
      "dosage_and_administration": [
        "Directions Apply a small amount to wet hands, and rub lightly together to produce a rich lather. Rinse hands thoroughly with water, and dry skin with a clean towel."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, glycerin, PEG-7 glyceryl cocoate, lauramine oxide, fragrance, linalool, amylcinnamaldehyde, butylphenyl methylpropional, geraniol, coumarin, benzyl salicylate, citric acid, edetate disodium, FD&C yellow no. 5, FD&C blue no. 1"
      ],
      "package_label_principal_display_panel": [
        "1 U.S. Gallon Bottle ANTI-BACTERIAL Foaming Hand Soap with Benzalkonium Chloride NET CONTENTS: 1 U.S. Gallon (3.78 l) Bottle Label Case Label",
        "1,000 ml bag Anti-Bacterial Foaming Hand Soap with Benzalkonium Chloride Net Contents: 1000 mL Simoniz Saniclean, LLC 299 Dividend Road Rocky Hill, CT 06067 1-800-227-5536 Bag Label Case Label"
      ],
      "set_id": "410c5f97-6c39-2571-e063-6394a90abe44",
      "id": "42da9705-3971-e180-e063-6394a90a83e2",
      "effective_time": "20251105",
      "version": "2",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Saniclean"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Simoniz Saniclean, LLC"
        ],
        "product_ndc": [
          "63900-110"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "rxcui": [
          "1046593"
        ],
        "spl_id": [
          "42da9705-3971-e180-e063-6394a90a83e2"
        ],
        "spl_set_id": [
          "410c5f97-6c39-2571-e063-6394a90abe44"
        ],
        "package_ndc": [
          "63900-110-01",
          "63900-110-02",
          "63900-110-03",
          "63900-110-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F5UM2KM3W7"
        ]
      }
    }
  ]
}