{
  "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": [
        "Sween 24 DIMETHICONE DIMETHICONE, UNSPECIFIED DIMETHICONE, UNSPECIFIED BEHENTRIMONIUM METHOSULFATE CETOSTEARYL ALCOHOL ETHYLHEXYL PALMITATE GLYCERIN ISOPROPYL PALMITATE PEG-150 PENTAERYTHRITYL TETRASTEARATE WATER"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Questions or comments? Call toll free 1-800-533-0464",
        "Manufactured by: Coloplast A/S, Holtedam 1, DK-3050 Humlebaek, Denmark Distributed by: Coloplast Corp, 1601 W River Rd N, Minneapolis, MN 55411 U.S.A."
      ],
      "active_ingredient": [
        "Active ingredient Dimethicone, 6%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Helps prevent and temporarily protects chafed, chapped or cracked skin and lips."
      ],
      "warnings": [
        "Warnings For external use only. Do not use on deep or puncture wounds animal bites serious burns When using this product Do not get into eyes Stop using this product if condition worsens symptoms last more than 7 days or clear up and occur again within a few days. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "do_not_use": [
        "Do not use on deep or puncture wounds animal bites serious burns"
      ],
      "when_using": [
        "When using this product Do not get into eyes"
      ],
      "stop_use": [
        "Stop using this product if condition worsens symptoms last more than 7 days or clear up and occur again within a few days."
      ],
      "keep_out_of_reach_of_children": [
        "Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions apply as needed"
      ],
      "inactive_ingredient": [
        "Inactive ingredients behentrimonium methosulfate, cetearyl alcohol, ethylhexyl palmitate, glycerin, isopropyl palmitate, PEG-5 ditrimethylolpropane tetrahydroxystearate, PEG-150 pentaerythrityl tetrastearate, water"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 57 g Tube Label NDC 11701-063-73 Sween ® 24 Moisturizer Once a Day Moisturizing Body Cream For Normal to Dry, Flaky, Itchy Skin Product #7091 Coloplast NET WT. 2 OZ. (57 g) PRINCIPAL DISPLAY PANEL - 57 g Tube Label"
      ],
      "set_id": "a623c8d7-8db0-410a-9980-02ac02f7b6ea",
      "id": "8435a838-1f5b-4d98-95eb-2f1b684a0e74",
      "effective_time": "20260327",
      "version": "9",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Sween 24"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Coloplast Corp"
        ],
        "product_ndc": [
          "11701-063"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE, UNSPECIFIED"
        ],
        "rxcui": [
          "577215"
        ],
        "spl_id": [
          "8435a838-1f5b-4d98-95eb-2f1b684a0e74"
        ],
        "spl_set_id": [
          "a623c8d7-8db0-410a-9980-02ac02f7b6ea"
        ],
        "package_ndc": [
          "11701-063-71",
          "11701-063-70",
          "11701-063-73",
          "11701-063-72"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}