{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Procure Dimethicone 5% Dimethicone NIACINAMIDE DIMETHICONE DIMETHICONE .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF ASCORBYL PALMITATE CANOLA OIL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETOSTEARYL ALCOHOL LEMON OIL, COLD PRESSED EDETATE DISODIUM ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE OLIVE OIL ORANGE OIL, COLD PRESSED PROPYLENE GLYCOL TROLAMINE VITAMIN A PALMITATE WATER ZEA MAYS (CORN) OIL PYRIDOXINE HCL PEG-100 MONOSTEARATE STEARIC ACID CHOLECALCIFEROL LAVENDER OIL PHENOXYETHANOL"
      ],
      "active_ingredient": [
        "Active Ingredient Dimethicone 5%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Uses temporaily protects and helps relieve chafed, chapped or cracked skin helps protect from the drying effects of whine and cold weather helps treat and prevent diaper rash protects minor skin irritation associated with diaper rash and helps seal out wetness"
      ],
      "warnings": [
        "Warnings Warnings For external use only When using this product When using this product do not get into eyes. Stop use and ask a doctor if 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 contact a physician or Poison Control Center right away."
      ],
      "when_using": [
        "When using this product When using this product do not get into eyes."
      ],
      "stop_use": [
        "Stop use and ask a doctor if 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 Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions Directions As a skin protectan t apply as needed As a diaper cream change wet and soiled diaper promptly, cleanse the diaper area and allow to dry apply cream liberally as often as necessary with each diaper change, expecially at bedtime or anytime when exposure to wet diaper may be prolonged"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Glyceryl Monostearate, Stearic Acid, PEG-100 Monostearate, Cetostearyl Alcohol, Glycerin, Propylene Glycol, Niacinamide, Pehenoxyethanol, Aloe Vera Leaf, Zea Mays Oil, Fragrance, Carbomer, Trolamine, Edetate Disodium, Orange Oil Cold Pressed, Canola Oil, Citrus Medica Limonum (Lemon) Peel Oil, Lavender Oil, Olive Oil, .Alpha.-Tocopherol Acetate, Ascorbyl Palmitate, Pyridoxine HCl, Vitamin A Palmitate, Cholecalciferol, Ethylhexylglycerin"
      ],
      "package_label_principal_display_panel": [
        "PCGD004 Image"
      ],
      "set_id": "38a7e4af-997d-549e-e063-6394a90a0bd6",
      "id": "38a7e4af-997e-549e-e063-6394a90a0bd6",
      "effective_time": "20250628",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Procure Dimethicone 5%"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Twin Med LLC"
        ],
        "product_ndc": [
          "55681-024"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "259090"
        ],
        "spl_id": [
          "38a7e4af-997e-549e-e063-6394a90a0bd6"
        ],
        "spl_set_id": [
          "38a7e4af-997d-549e-e063-6394a90a0bd6"
        ],
        "package_ndc": [
          "55681-024-04",
          "55681-024-05",
          "55681-024-14"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}