{
  "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 DIMETHICONE DIMETHICONE NIACINAMIDE TETRASODIUM GLUTAMATE DIACETATE ASCORBIC ACID PYRIDOXINE HYDROCHLORIDE WATER STEARYL ALCOHOL CORN OIL .ALPHA.-TOCOPHEROL, DL- GLYCERIN STEARIC ACID VITAMIN A PALMITATE CANOLA OIL CETYL ALCOHOL CHOLECALCIFEROL PHENOXYETHANOL PEG-100 STEARATE ASCORBYL PALMITATE DIMETHYL SULFONE PROPANEDIOL ALOE VERA LEAF ACETYLCYSTEINE TAURINE PROLINE ARGININE GLYCERYL STEARATE SE ANHYDROUS CITRIC ACID ETHYLHEXYLGLYCERIN GLYCINE PEG-8 OLEA EUROPAEA (OLIVE) FRUIT OIL OLEA EUROPAEA (OLIVE) LEAF OLEA EUROPAEA (OLIVE) FRUIT"
      ],
      "active_ingredient": [
        "Active ingredient Dimethicone 1.5% w/w"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses helps prevent and temporarily protects and helps relieve chapped or cracked skin helps prevent and protect from the drying effects of wind and cold weather"
      ],
      "warnings": [
        "Warnings For external use only Do not use deep or puncture wounds animal bites serious burns 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."
      ],
      "do_not_use": [
        "Do not use deep or puncture wounds animal bites serious burns"
      ],
      "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 to full body as needed"
      ],
      "other_safety_information": [
        "Other information protect from freezing avoid excessive heat not made with Natural Rubber Latex"
      ],
      "inactive_ingredient": [
        "Inactive ingredients acetyl cysteine, aloe barbadensis leaf juice, arginine, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol, citric acid, dimethyl sulfone, ethylhexylglycerin, glycerin, glyceryl stearate, glycine, niacinamide, olea europaea (olive) fruit extract, olea europaea (olive) fruit oil, olea europaea (olive) leaf extract, PEG-8, PEG-100 stearate, phenoxyethanol, proline, propanediol, pyridoxine HCl, retinyl palmitate, stearic acid, stearyl alcohol, taurine, tetrasodium glutamate diacetate, tocopherol, water, zea mays (corn) oil"
      ],
      "spl_unclassified_section": [
        "Manufacturing Information www.medline.com ©2025 Medline and Medline Remedy are registered trademarks of Medline Industries, LP. Made in USA of foreign and domestic materials Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA 1-800-MEDLINE REF: MSC0924402UNS"
      ],
      "recent_major_changes": [
        "Directions update Updated verbiage to align with M016"
      ],
      "package_label_principal_display_panel": [
        "Label"
      ],
      "set_id": "0d964138-f68d-dbf5-e063-6294a90a8320",
      "id": "5a096e34-45e4-2d7d-e063-6294a90aad9a",
      "effective_time": "20260827",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Medline"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-155"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "309917"
        ],
        "spl_id": [
          "5a096e34-45e4-2d7d-e063-6294a90aad9a"
        ],
        "spl_set_id": [
          "0d964138-f68d-dbf5-e063-6294a90a8320"
        ],
        "package_ndc": [
          "53329-155-13",
          "53329-155-04",
          "53329-155-23",
          "53329-155-84"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}