{
  "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": [
        "Oatmeal Skin Relief Calming . 8oz Dimethicone CETYL ALCOHOL ISOPROPYL MYRISTATE LAURETH-7 MAGNESIUM DISODIUM EDTA POLYACRYLAMIDE (10000 MW) C13-14 ISOPARAFFIN CETYL STEARATE PEG-100 STEARATE DMDM HYDANTOIN METHYLPARABEN WATER PETROLATUM GLYCERIN PROPYLENE GLYCOL STEARYL ALCOHOL DIMETHICONE DIMETHICONE OAT KERNEL OIL DISTEARYLDIMONIUM CHLORIDE DISTEARYLDIMONIUM"
      ],
      "active_ingredient": [
        "Active Ingredient Dimethicone 1.3%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "indications_and_usage": [
        "Use Help prevent and temporarily protects chafed, chapped, or cracked skin."
      ],
      "warnings": [
        "Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush with water. Do not use on Deep or puncture wounds Animal bites Serious burns Stop use and ask a doctor if conditions worsens. Symptoms last more than 7 days or clear up and occur again within a few days."
      ],
      "dosage_and_administration": [
        "Directions apply liberally as often as needed."
      ],
      "other_safety_information": [
        "Other Information store at room temperature."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Petrolatum, Cetyl Alcohol, Glyceryl Stearate, Propylene Glycol, Glycerin, Stearyl Alcohol, PEG-100 Stearate, Polyacrylamide, DMDM Hydrantoin, Isopropyl Myristate, Fragrance, C13-14 Isoparaffin, Laureth-7, Avena Sativa (Oat) Kernel Extract, Disodium EDTA, Methylparaben, Propylparaben"
      ],
      "package_label_principal_display_panel": [
        "label"
      ],
      "set_id": "8384dc52-ba36-da3d-e053-2a91aa0a4f40",
      "id": "8384b028-7b9c-2a7b-e053-2a91aa0a342c",
      "effective_time": "20190307",
      "version": "1",
      "openfda": {
        "application_number": [
          "part347"
        ],
        "brand_name": [
          "Oatmeal Skin Relief Calming . 8oz"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Rejoice International Inc."
        ],
        "product_ndc": [
          "57337-100"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "891710"
        ],
        "spl_id": [
          "8384b028-7b9c-2a7b-e053-2a91aa0a342c"
        ],
        "spl_set_id": [
          "8384dc52-ba36-da3d-e053-2a91aa0a4f40"
        ],
        "package_ndc": [
          "57337-100-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0849607065506"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}