{
  "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": [
        "Colloidal oatmeal Colloidal oatmeal WATER GLYCERIN DISTEARYLDIMONIUM CHLORIDE PETROLATUM ISOPROPYL PALMITATE CETYL ALCOHOL DIMETHICONE, UNSPECIFIED PANTHENOL OAT KERNEL OIL STEARETH-20 BENZALKONIUM CHLORIDE CERAMIDE NP SODIUM CHLORIDE BENZYL ALCOHOL SODIUM HYDROXIDE OATMEAL OATMEAL"
      ],
      "active_ingredient": [
        "Active ingredient Colloidal oatmeal 1%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily protects and helps relieve minor skin irritation and itching due to: eczema rashes"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "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 right away."
      ],
      "dosage_and_administration": [
        "Directions apply as needed"
      ],
      "spl_unclassified_section": [
        "Other information store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, glycerin, distearyldimonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol, dimethicone, panthenol, Avena sativa (oat) kernel oil, steareth-20, benzalkonium chloride, ceramide NP, sodium chloride, benzyl alcohol, sodium hydroxide"
      ],
      "adverse_reactions": [
        "adverse reactions We hope you are satisfied with this product. If not, we will cheerfully refund your money. DISTRIBUTED BY: H-E-B ® , SAN ANTONIO, TX 78204 MADE IN THE USA WTH U.S. AND FOREIGN COMPONENTS LOT NUMBER: ON PACKAGE QUESTIONS OR COMMENTS? CALL TOLL FREE 1-888-593-0593"
      ],
      "package_label_principal_display_panel": [
        "principal display panel HILL COUNTRY™ ESSENTIALS Baby Eczema Therapy Cream COLLOIDAL OATMEAL SKIN PROTECTANT FREE FROM parabens phthalates dyes NET WT. 5 OZ CONT. NET. 141 g image description",
        "PRINCIPAL DISPLAY PANEL HILL COUNTRY FARE ® Baby Eczema Therapy Cream COLLOIDAL OATMEAL SKIN PROTECTANT FREE FROM parabens phthalates dyes NET WT. 5 OZ CONT. NET. 141 g image description"
      ],
      "set_id": "ce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba",
      "id": "4b93fc15-eb48-5e70-e063-6394a90a09bc",
      "effective_time": "20260224",
      "version": "11",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Colloidal oatmeal"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "H E B"
        ],
        "product_ndc": [
          "37808-128"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "240651"
        ],
        "spl_id": [
          "4b93fc15-eb48-5e70-e063-6394a90a09bc"
        ],
        "spl_set_id": [
          "ce9ffcc1-a4c3-4771-ae27-ba99c74bb1ba"
        ],
        "package_ndc": [
          "37808-128-28"
        ],
        "is_original_packager": [
          true
        ],
        "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"
        ]
      }
    }
  ]
}