{
  "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": [
        "A-Cute Derm Antisepation Benzethonium Chloride AMMONIUM LAURYL SULFATE HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE HYPROMELLOSES SODIUM CHLORIDE DIAZOLIDINYL UREA PEG-4 LAURATE METHYLPARABEN IODOPROPYNYL BUTYLCARBAMATE LAURAMIDOPROPYL BETAINE PROPYLPARABEN PROPYLENE GLYCOL BENZETHONIUM CHLORIDE BENZETHONIUM WATER"
      ],
      "statement_of_identity": [
        "DRUG FACTS A-Cute Derm Antisepation Cleansing Gel"
      ],
      "active_ingredient": [
        "Active Ingredients Benzethonium Chloride (0.2%)"
      ],
      "purpose": [
        "Purpose Antimicrobial"
      ],
      "indications_and_usage": [
        "Uses Antisepation™ is a unique, non-drying cleanser. •Designed for all skin types and pH balanced. •Excellent for postoperative care. •May be used as a topical antimicrobial to help protect against skin infection."
      ],
      "warnings": [
        "Warnings For external use only. Do not use in eyes. Ask a doctor before use if you have deep wounds or puncture wounds. Stop use and ask a doctor if irritation develops. Keep out of reach of children."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Directions •Wet hands and other areas to be treated. •Place a small amount of gel in your hands and work into lather. •Apply lather to areas to be treated using a gentle, circular motion. •Rinse clean."
      ],
      "other_safety_information": [
        "Other Information •Alcohol Free •Moisturizes •Made in USA"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Hydroxypropyl Bis-Hydroxyethyl-dimonium Chloride, Propylene Glycol, Hydroxypropylmethylcellulose, Sodium Chloride, Diazolidinyl Urea, PEG-4 Laurate, Methylparaben, Propylparaben, 3-iodo-2-propynylbutylcarbamate."
      ],
      "questions": [
        "Questions or Comments Distributed by ABBE Laboratories, Inc. 1095 Route 110 Farmingdale, NY 11735 1-800-457-0990"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel A-Cute Derm® medical skincare Antisepation™ Cleansing Gel 8.0 FL OZ (236.6 ml) antisepation cleansing gel"
      ],
      "set_id": "d7e69169-dc8a-4ad7-b8bb-d97a5d30cbec",
      "id": "3a172d4c-117c-4e15-b710-7d78a9146b69",
      "effective_time": "20260124",
      "version": "3",
      "openfda": {
        "application_number": [
          "M004"
        ],
        "brand_name": [
          "A-Cute Derm Antisepation"
        ],
        "generic_name": [
          "BENZETHONIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "ABBE Laboratories, Inc."
        ],
        "product_ndc": [
          "68605-7171"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "CUTANEOUS"
        ],
        "substance_name": [
          "BENZETHONIUM CHLORIDE"
        ],
        "spl_id": [
          "3a172d4c-117c-4e15-b710-7d78a9146b69"
        ],
        "spl_set_id": [
          "d7e69169-dc8a-4ad7-b8bb-d97a5d30cbec"
        ],
        "package_ndc": [
          "68605-7171-4",
          "68605-7171-2",
          "68605-7171-8"
        ],
        "original_packager_product_ndc": [
          "25280-005"
        ],
        "unii": [
          "PH41D05744"
        ]
      }
    }
  ]
}