{
  "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": [
        "Medline Dimethicone CETEARYL ALCOHOL DIMETHICONE DIMETHICONE WATER ETHYLHEXYL PALMITATE BEHENTRIMONIUM METHOSULFATE GLYCERIN PEG-5 DITRIMETHYLOLPROPANE TETRAHYDROXYSTEARATE ISOPROPYL PALMITATE PEG-150 PENTAERYTHRITYL TETRASTEARATE"
      ],
      "active_ingredient": [
        "Active ingredient Dimethicone 6.6% w/w"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses helps prevent and temporarily protects and helps relieve chapped or cracked skin and lips"
      ],
      "warnings": [
        "Warnings For external use only When using this product do not get into eyes Stop use and ask a doctor 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. In case of accidental ingestion, get medical help or contact a Poison Control Center right away"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor 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 out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away"
      ],
      "dosage_and_administration": [
        "Directions apply as needed."
      ],
      "storage_and_handling": [
        "Other information protect from freezing avoid excessive heat"
      ],
      "inactive_ingredient": [
        "Inactive ingredients behentrimonium methosulfate, cetearyl alcohol, ethylhexyl palmitate, glycerin, isopropyl palmitate, PEG-5 ditrimethylolpropane tetrahydroxystearate, PEG-150 pentaerythrityl tetrastearate, water"
      ],
      "questions": [
        "Questions? 1-800-MEDLINE (633-5463)"
      ],
      "spl_unclassified_section": [
        "Manufacturing information"
      ],
      "package_label_principal_display_panel": [
        "Package Label Package Label-Front Package Label-Back"
      ],
      "set_id": "3c448cf7-8ca5-c7f7-e063-6294a90a75ff",
      "id": "50a03f0b-b618-c7ec-e063-6294a90a48e3",
      "effective_time": "20260608",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Medline"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-259"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "spl_id": [
          "50a03f0b-b618-c7ec-e063-6294a90a48e3"
        ],
        "spl_set_id": [
          "3c448cf7-8ca5-c7f7-e063-6294a90a75ff"
        ],
        "package_ndc": [
          "53329-259-14",
          "53329-259-64",
          "53329-259-74"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}