{
  "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": [
        "TRI-SOFT SOFTENING BENZALKONIUM CHLORIDE WATER BENZYL ALCOHOL PHENYLMERCURIC NITRATE POLYSORBATE 20 ALCOHOL BENZALKONIUM CHLORIDE BENZALKONIUM"
      ],
      "spl_unclassified_section": [
        "TRI-SOFT SOFTENING SOLUTION",
        "Tri-Soft Softening Solution is a rapid-acting emulsifying agent combined with antiseptic properties. It is specifically formulated for use on the skin prior to instrument reduction of hyperkeratotic lesions."
      ],
      "active_ingredient": [
        "Active Ingredient BENZALKONIUM CHLORIDE (0.13 %)"
      ],
      "purpose": [
        "Purpose Antiseptic"
      ],
      "indications_and_usage": [
        "Uses: For antiseptic cleansing that will decrease bacteria on the skin without soap and water."
      ],
      "warnings": [
        "Warnings For external use only. Do not use in the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and consult a physician if irritation or redness develops and persists for more than 72 hours. Do not bandage tightly. If pregnant or breast feeding, contact physician prior to use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children if swallowed, consult physician or poison control immediately"
      ],
      "dosage_and_administration": [
        "Directions Mix 1 part Tri-Soft Concentrate with water q. s. to 16 parts. Saturate cotton and place over hyperkeratotic tissues for 3 minutes before reduction or debridement."
      ],
      "inactive_ingredient": [
        "Other Ingredients Aqua (Deionized Water), Benzyl Alcohol, Phenylmercuric Nitrate, Polysorbate-20, SD-Alcohol 40B."
      ],
      "package_label_principal_display_panel": [
        "TRI-SOFT SOFTENING SOLUTION 8oz (44577-711-08) TRISOFT"
      ],
      "set_id": "3d2bd5ab-5288-4d7d-b9e6-1b737a791bdb",
      "id": "0973c7d8-bd6d-e83b-e063-6294a90acf55",
      "effective_time": "20231105",
      "version": "4",
      "openfda": {
        "application_number": [
          "505G(a)(3)"
        ],
        "brand_name": [
          "TRI-SOFT SOFTENING"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Clinical Therapeutic Solutions"
        ],
        "product_ndc": [
          "44577-711"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "rxcui": [
          "1046593"
        ],
        "spl_id": [
          "0973c7d8-bd6d-e83b-e063-6294a90acf55"
        ],
        "spl_set_id": [
          "3d2bd5ab-5288-4d7d-b9e6-1b737a791bdb"
        ],
        "package_ndc": [
          "44577-711-08"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0859935003071"
        ],
        "unii": [
          "F5UM2KM3W7"
        ]
      }
    }
  ]
}