{
  "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 ACETYL CYSTEINE ALOE BARBADENSIS LEAF JUICE ARGININE ASCORBIC ACID ASCORBYL PALMITATE CANOLA OIL CETYL ALCOHOL CHOLECALCIFEROL CITRIC ACID DIMETHYL SULFONE ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL STEARATE SE GLYCINE NIACINAMIDE OLEA EUROPAEA (OLIVE) FRUIT OIL OLEA EUROPAEA (OLIVE) LEAF POWDER PEG-8 PEG-100 STEARATE PHENOXYETHANOL PROLINE PROPANEDIOL PYRIDOXINE HYDROCHLORIDE RETINYL PALMITATE STEARIC ACID STEARYL ALCOHOL TAURINE TETRASODIUM GLUTAMATE DIACETATE TOCOPHEROL WATER ZEA MAYS (CORN) OIL OLEA EUROPAEA (OLIVE) FRUIT"
      ],
      "active_ingredient": [
        "Active ingredient Dimethicone 1.5% w/w"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily protects and helps relieve chapped or cracked skin."
      ],
      "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 use and ask a doctor if condition worsens, symptoms last for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "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 use and ask a doctor if condition worsens, symptoms last for 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. If swallowed, 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 acetyl cysteine, aloe barbadensis leaf juice, arginine, ascorbic acid, ascorbyl palmitate, canola oil, cetyl alcohol, cholecalciferol, citric acid, dimethyl sulfone, ethylhexylglycerin, glycerin, glyceryl stearate SE, 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, pryidoxine HCl, retinyl palmitate, stearic acid, stearyl alcohol, taurine, tetrasodium glutamate diacetate, tocopherol, water, zea mays (corn) oil"
      ],
      "spl_unclassified_section": [
        "Manufacturing information Medline Remedy is a registered trademark of Medline Industries, LP, Olivamine is a registered trademark of McCord Research, Inc. Manufactured for: Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA. Made in USA of domestic and imported materials. www.medline.com 1-800-MEDLINE"
      ],
      "package_label_principal_display_panel": [
        "Package Label label"
      ],
      "set_id": "5afb3595-f014-153e-e063-6294a90ad34b",
      "id": "5afb3595-f015-153e-e063-6294a90ad34b",
      "effective_time": "20260908",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Medline"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-149"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "spl_id": [
          "5afb3595-f015-153e-e063-6294a90ad34b"
        ],
        "spl_set_id": [
          "5afb3595-f014-153e-e063-6294a90ad34b"
        ],
        "package_ndc": [
          "53329-149-86"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}