{
  "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": [
    {
      "effective_time": "20190308",
      "inactive_ingredient": [
        "Inactive ingredients Water, Glycerin, Petrolatum, Cetearyl Alcohol, Dimethicone, Isopropyl Myristate, Distearyldimonium Chloride, Steareth-2, Avena Sativa (Oat) Kernel Extract, Phenoxyethanol, Steareth-21, Sodium Chloride, Benzalkonium Chloride, Panthenol, Ceramide NP, Avena Sativa (Oat) Kernel Oil"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "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 immediately."
      ],
      "warnings": [
        "Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush with water. Stop using this product and ask a doctor if condition worsens, or if symptoms last more than 7 days, or if they 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 immediately."
      ],
      "when_using": [
        "When using this product avoid contact with eyes. In case of eye contact, flush with water. Stop using this product and ask a doctor if condition worsens, or if symptoms last more than 7 days, or if they 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 immediately."
      ],
      "spl_product_data_elements": [
        "Eczema Care Moisturizing 3 oz. Colloidal Oatmeal WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PANTHENOL PETROLATUM ISOPROPYL MYRISTATE CETYL ALCOHOL DIMETHICONE OAT KERNEL OIL STEARETH-20 OAT BENZALKONIUM CHLORIDE CERAMIDE NP SODIUM CHLORIDE OATMEAL OATMEAL PHENOXYETHANOL STEARETH-2 CETOSTEARYL ALCOHOL"
      ],
      "openfda": {
        "application_number": [
          "part347"
        ],
        "brand_name": [
          "Eczema Care Moisturizing 3 oz."
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Rejoice International Inc."
        ],
        "product_ndc": [
          "57337-101"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "spl_id": [
          "83966e75-3cf0-410b-e053-2a91aa0a90f3"
        ],
        "spl_set_id": [
          "83967d26-159a-e95c-e053-2991aa0af53a"
        ],
        "package_ndc": [
          "57337-101-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0849607065490"
        ],
        "nui": [
          "N0000185371",
          "N0000185375",
          "N0000175629",
          "N0000184306",
          "M0000728",
          "M0006342",
          "M0016962",
          "N0000185016"
        ],
        "pharm_class_epc": [
          "Non-Standardized Food Allergenic Extract [EPC]",
          "Non-Standardized Plant Allergenic Extract [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Dietary Proteins [CS]",
          "Plant Proteins [CS]"
        ],
        "unii": [
          "8PI54V663Y"
        ]
      },
      "version": "1",
      "dosage_and_administration": [
        "Directions Apply as needed"
      ],
      "stop_use": [
        "Stop using this product and ask a doctor if condition worsens, or if symptoms last more than 7 days, or if they 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 immediately."
      ],
      "storage_and_handling": [
        "Other information store at room temperature."
      ],
      "package_label_principal_display_panel": [
        "Label copy label"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve minor skin itching and irritation due to: Eczema Rashes"
      ],
      "set_id": "83967d26-159a-e95c-e053-2991aa0af53a",
      "id": "83966e75-3cf0-410b-e053-2a91aa0a90f3",
      "active_ingredient": [
        "Active ingredient Colloidal Oatmeal 1% Purpose Skin protectant"
      ]
    }
  ]
}