{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "XtraCare Oatmeal Daily Moisturizing 8 oz Dimethicone STEARYL ALCOHOL METHYLPARABEN GLYCERYL MONOSTEARATE GLYCERIN DMDM HYDANTOIN PETROLATUM OAT PEG-100 STEARATE WATER EDETATE DISODIUM DIMETHICONE DIMETHICONE PROPYLPARABEN POLYACRYLAMIDE (10000 MW) C13-14 ISOPARAFFIN ISOPROPYL MYRISTATE LAURETH-7 PROPYLENE GLYCOL CETYL ALCOHOL"
      ],
      "active_ingredient": [
        "Active ingredient Dimethicone 1.3%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses 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 condition worsens. Symptoms last 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 immediately."
      ],
      "when_using": [
        "When using this product avoid contact with eyes. In case of eye contact, flush with water."
      ],
      "do_not_use": [
        "Do not use on deep or puncture wounds animal bites serious burns"
      ],
      "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. If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions a pply liberally as often as needed."
      ],
      "storage_and_handling": [
        "Other information Store at room temperature."
      ],
      "inactive_ingredient": [
        "Water, Petrolatum, Cetyl Alcohol, Glyceryl Stearate, Propylene Glycol, Glycerin, Stearyl Alcohol, PEG-100 Stearate, Polyacrylamide, DMDM Hydantoin, Isopropyl Myristate, Fragrance, C13-14 Isoparaffin, Laureth-7, Avena Sativa (Oat) Kernel Extract, Disodium, EDTA, Methylparaben, Propylparaben."
      ],
      "questions": [
        "Questions/comments? 1-855-345-5575"
      ],
      "package_label_principal_display_panel": [
        "Bottle Label"
      ],
      "set_id": "c055d5fb-7398-26e4-e053-2995a90acd41",
      "id": "2e12de28-f85b-9518-e063-6394a90ae58f",
      "effective_time": "20250213",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "XtraCare Oatmeal Daily Moisturizing 8 oz"
        ],
        "generic_name": [
          "DIMETHICONE"
        ],
        "manufacturer_name": [
          "Rejoice International Inc."
        ],
        "product_ndc": [
          "57337-138"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIMETHICONE"
        ],
        "rxcui": [
          "891710"
        ],
        "spl_id": [
          "2e12de28-f85b-9518-e063-6394a90ae58f"
        ],
        "spl_set_id": [
          "c055d5fb-7398-26e4-e053-2995a90acd41"
        ],
        "package_ndc": [
          "57337-138-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0849607069023"
        ],
        "nui": [
          "N0000010282"
        ],
        "pharm_class_pe": [
          "Skin Barrier Activity [PE]"
        ],
        "unii": [
          "92RU3N3Y1O"
        ]
      }
    }
  ]
}