{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "GLADSKIN ECZEMACT ECZEMA COLLOIDAL OATMEAL OATMEAL OATMEAL WATER GLYCERIN PETROLATUM CETOSTEARYL ALCOHOL MINERAL OIL ARGININE HYDROCHLORIDE SODIUM CHLORIDE POLYOXYL 20 CETOSTEARYL ETHER TROMETHAMINE CALCIUM CHLORIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Company Information Distributed by Micreos North America, Inc. Encinitas, CA 92024 gladskin.com"
      ],
      "active_ingredient": [
        "Active Ingredient Colloidal Oatmeal (0.02%)"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Temporarily protects and helps relieve minor skin irritation and itching due to eczema."
      ],
      "warnings": [
        "Warnings For external use only. When using this product do not get into eyes. Stop use and ask a doctor if: Conditions worsen 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 right away."
      ],
      "when_using": [
        "When using this product do not get into eyes."
      ],
      "stop_use": [
        "Stop use and ask a doctor if: Conditions worsen 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"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Water, Glycerin, Petrolatum, Mineral Oil, Cetearyl Alcohol, Ceteareth-20, Arginine HCl, Sodium Chloride, Tromethamine, Calcium Chloride, sr-(Methionyl Staphylococcus Simulans Polypeptide-1 Dipeptide-53 Staphylococcus Phage 2638A Polypeptide-1)* *Micreobalance™ is a proprietary smart protein that rebalances the skin microbiome."
      ],
      "questions": [
        "Questions? (888) 802-1668"
      ],
      "package_label_principal_display_panel": [
        "Product Packaging 1"
      ],
      "set_id": "06f9af75-c5ff-d37b-e063-6394a90a4f6c",
      "id": "4ba8734b-a8bf-515e-e063-6394a90a892d",
      "effective_time": "20260225",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "GLADSKIN ECZEMACT ECZEMA"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Micreos North America, Inc."
        ],
        "product_ndc": [
          "73105-003"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "2267204"
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        "spl_id": [
          "4ba8734b-a8bf-515e-e063-6394a90a892d"
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        "spl_set_id": [
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        "package_ndc": [
          "73105-003-50",
          "73105-003-00"
        ],
        "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"
        ]
      }
    }
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}