{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Claravie Benzalkonium Chloride BENZALKONIUM CHLORIDE BENZALKONIUM WATER SODIUM LAURETH SULFATE TRIETHANOLAMINE LAURYL SULFATE COCAMIDE MEA POLYQUATERNIUM-7 SODIUM CHLORIDE GLYCERYL DISTEARATE SODIUM BENZOATE PEG-7 GLYCERYL COCOATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE ALOE VERA LEAF BUTYROSPERMUM PARKII (SHEA) BUTTER CITRIC ACID D&C RED NO. 33 D&C YELLOW NO. 10 COCAMIDOPROPYL BETAINE SODIUM C14-16 OLEFIN SULFONATE"
      ],
      "active_ingredient": [
        "Active Ingredient Benzalkonium Chloride 0.1%"
      ],
      "purpose": [
        "Purpose Antiseptic / Antibacterial"
      ],
      "indications_and_usage": [
        "Uses For hand washing to decrease bacteria on skin. Recommended for repeated use for body wash to help reduce bacteria that can potentially cause disease"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "do_not_use": [
        "Do not use on wounds or damaged skin on a child under 12 years of age"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have redness over the affected area."
      ],
      "dosage_and_administration": [
        "When using this product use only as directed avoid contact with eyes or mucous membranes."
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition persists or gets worse. Do not use longer than 1 week unless directed by 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."
      ],
      "instructions_for_use": [
        "Directions Apply to hands and wet as needed, vigorously work into a lather and rinse thoroughly."
      ],
      "storage_and_handling": [
        "Other Information Store at room temperature."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Sodium Laureth Sulfate, Triethanolamine Lauryl Sulfate, Cocamidopropyl Betaine (CAPB), Cocamide MEA, Polyquaternium 7, Sodium Chloride, Glyceryl Distearate, Sodium Benzoate, PEG-7 Glyceryl Cocoate, Fragrance, Sodium C14-15 Olefin Sulfonate, Methylchloroisothiazolinone and Methylisothiazolinone, Aloe Barbadensis Gel, Butyrospermum Parkii (Shea Butter), Citric Acid, D&C RED # 33, D&C YELLOW # 10"
      ],
      "questions": [
        "1-800-840-9041 www.gentell.com"
      ],
      "package_label_principal_display_panel": [
        "Antibacterial Lotion Soap Antibacterial Lotion Soap Label: Antibacterial lotion soap"
      ],
      "set_id": "59887af3-9b22-9664-e063-6294a90a57c6",
      "id": "59887af3-9b23-9664-e063-6294a90a57c6",
      "effective_time": "20260821",
      "version": "1",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "Claravie"
        ],
        "generic_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "Gentell LLC"
        ],
        "product_ndc": [
          "61554-315"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZALKONIUM CHLORIDE"
        ],
        "rxcui": [
          "1233282"
        ],
        "spl_id": [
          "59887af3-9b23-9664-e063-6294a90a57c6"
        ],
        "spl_set_id": [
          "59887af3-9b22-9664-e063-6294a90a57c6"
        ],
        "package_ndc": [
          "61554-315-41"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "F5UM2KM3W7"
        ]
      }
    }
  ]
}