{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Total Solutions Hygien Hand Benzalkonium WATER FD&C RED NO. 40 FD&C YELLOW NO. 5 ANHYDROUS CITRIC ACID POLOXAMER 124 LAURAMIDOPROPYLAMINE OXIDE MYRISTAMIDOPROPYLAMINE OXIDE PEG-6 COCAMIDE HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) GLYCERIN BENZYL ALCOHOL PHENOXYETHANOL BENZALKONIUM CHLORIDE BENZALKONIUM"
      ],
      "active_ingredient": [
        "Active ingredient Benzalkonium Chloride 0.12%"
      ],
      "purpose": [
        "Purpose Antiseptic"
      ],
      "indications_and_usage": [
        "Uses ■ For handwashing to help reduce bacteria on skin. ■ After changing diapers. ■ After assisting ill persons. ■ Before contact with a person under medical care or treatment. ■ Recommended for repeat use."
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "do_not_use": [
        "Do not use in the eyes"
      ],
      "when_using": [
        "When using this product do not get into eyes. If contact occurs, rinse thoroughly with water."
      ],
      "stop_use": [
        "Stop use and ask a doctor if irritation and redness develop. If condition persists for more than 72 hours consult a doctor."
      ],
      "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 forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub hands thoroughly. Rinse with water and repeat."
      ],
      "other_safety_information": [
        "Other information ■ Store in a cool, dry place."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water, Poloxamer 124, Lauramidopropylamine Oxide; PEG-3 Cocamide, Hydroxyethylcellulose, Glycerin, Myristamidopropylamine oxide, Benzyl Alcohol, Fragrance, Phenoxyethanol, Citric Acid, FD&C Yellow Number 5, FD&C Red Number 40."
      ],
      "package_label_principal_display_panel": [
        "62819-268-01.jpg 62819-260-01.jpg",
        "62819-268-02.jpg 62819-268-02"
      ],
      "set_id": "fcd63fe4-a357-4432-a738-ae1bccbb8bae",
      "id": "2a8551bf-9018-2a4d-e063-6294a90a15e7",
      "effective_time": "20241230",
      "version": "4",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "Total Solutions Hygien Hand"
        ],
        "generic_name": [
          "BENZALKONIUM"
        ],
        "manufacturer_name": [
          "Athea Laboratories, Inc."
        ],
        "product_ndc": [
          "62819-268"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "rxcui": [
          "1053188"
        ],
        "spl_id": [
          "2a8551bf-9018-2a4d-e063-6294a90a15e7"
        ],
        "spl_set_id": [
          "fcd63fe4-a357-4432-a738-ae1bccbb8bae"
        ],
        "package_ndc": [
          "62819-268-01",
          "62819-268-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F5UM2KM3W7"
        ]
      }
    }
  ]
}