{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Guardelle BENZALKONIUM CHLORIDE BENZALKONIUM CHLORIDE BENZALKONIUM Water COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE PROPYLENE GLYCOL TRIETHYLENE GLYCOL POLYSORBATE 20"
      ],
      "active_ingredient": [
        "Active Ingredient Benzalkonium chloride 0.13%"
      ],
      "purpose": [
        "Purpose Antiseptic"
      ],
      "indications_and_usage": [
        "Uses To decrease bacteria on the skin"
      ],
      "warnings": [
        "Warnings For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if skin/eye irritation develops."
      ],
      "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."
      ],
      "do_not_use": [
        "Do not use in eyes. In case of contact, rinse eyes thoroughly with water."
      ],
      "stop_use": [
        "Stop use and ask a doctor if skin/eye irritation develops."
      ],
      "dosage_and_administration": [
        "Directions Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of the product."
      ],
      "spl_unclassified_section": [
        "Other Information • Avoid extreme temperatures."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Cocamidolpropyl PG-Dimonium Chloride Phospate, Propylene glycol, Triethylene glycol, Polysorbate-20"
      ],
      "package_label_principal_display_panel": [
        "Guardelle WATER-BASED FOAMING HAND SANITIZER kills 99.9% of common germs & bacteria in 15 seconds 97% water Moisturizing, Alcohol-Free Safe for all hands All clean with just 1 pump Manufactured for WellBefore 2015 Mckenzie Dr. STE 106 Carrollton, TX, 75006. Made in the USA wellbefore.com 1.7 OZ 7.0 OZ 18 OZ res FRRONT 1.75 BACK 1.75 san FRONT 7.0 Back 7.0 FRONTT 18 BACKK 18"
      ],
      "set_id": "8793e3be-7409-4f71-9397-abbeacd27cf8",
      "id": "3a8774ed-4fdf-48b6-a54b-8db85492cb34",
      "effective_time": "20251222",
      "version": "1",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "Guardelle"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Social Medical Supply LLC"
        ],
        "product_ndc": [
          "85754-000"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "rxcui": [
          "1020365"
        ],
        "spl_id": [
          "3a8774ed-4fdf-48b6-a54b-8db85492cb34"
        ],
        "spl_set_id": [
          "8793e3be-7409-4f71-9397-abbeacd27cf8"
        ],
        "package_ndc": [
          "85754-000-02",
          "85754-000-07",
          "85754-000-18"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F5UM2KM3W7"
        ]
      }
    }
  ]
}