{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "SunDrops 77 Benzalkonium Chloride PANTHENOL PHENOXYETHANOL CITRIC ACID MONOHYDRATE WATER BENZALKONIUM CHLORIDE BENZALKONIUM PROPYLENE GLYCOL LAURAMINE OXIDE GLYCERIN water white - colorless, dispensed as a white foam"
      ],
      "active_ingredient": [
        "Active Ingredient Benzalkonium Chloride 0.1%"
      ],
      "purpose": [
        "Purpose Antimicrobial"
      ],
      "indications_and_usage": [
        "Uses For hand sanitizing to decrease bacteria on the skin Recommended for repeated use"
      ],
      "warnings": [
        "Warnings For external use only . When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if 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."
      ],
      "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 Pump a small amount of foam into palm of hand. Rub thoroughly over all surfaces of both hands. Rub hands together briskly until dry."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Glycerin, Propylene Glycol, Phenoxyethanol, Lauramine Oxide, Panthenol, Fragrance, Citric Acid"
      ],
      "package_label_principal_display_panel": [
        "Case Label - 8 x 1000 mL Bags"
      ],
      "set_id": "fc0ba65c-5307-4251-a60b-cde84ad56ad8",
      "id": "43535ccc-3e06-c1e0-e063-6294a90a3acb",
      "effective_time": "20251111",
      "version": "9",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "SunDrops 77"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Sunburst Chemicals, Inc."
        ],
        "product_ndc": [
          "63621-354"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "spl_id": [
          "43535ccc-3e06-c1e0-e063-6294a90a3acb"
        ],
        "spl_set_id": [
          "fc0ba65c-5307-4251-a60b-cde84ad56ad8"
        ],
        "package_ndc": [
          "63621-354-85",
          "63621-354-70",
          "63621-354-40"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F5UM2KM3W7"
        ]
      }
    }
  ]
}