{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Derma E Eczema Relief Oatmeal OATMEAL OATMEAL ALLANTOIN ARCTIUM LAPPA ROOT ARCTOSTAPHYLOS UVA-URSI LEAF MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE CETYL ALCOHOL MATRICARIA CHAMOMILLA FLOWERING TOP COCO-CAPRYLATE COPTIS CHINENSIS ROOT DIMETHICONE ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL STEARATE SE GLYCERYL STEARATE CITRATE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE AZADIRACHTA INDICA LEAF PHENOXYETHANOL POTASSIUM SORBATE WATER JOJOBA OIL SODIUM HYDROXIDE STEARIC ACID D7 STEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE, DL-"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by DERMA E ® Simi Valley, CA, 93065"
      ],
      "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 or Rashes"
      ],
      "warnings": [
        "Warnings For external use only When using this product Do not get into eyes 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 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 immediately"
      ],
      "dosage_and_administration": [
        "Directions Apply as needed to entire body, concentrating on areas of dryness"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Allantoin, Arctium Lappa Root Extract, Arctostaphylos Uva-Ursi Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Glucoside, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower, Coco-Caprylate, Coptis Chinensis Root Extract, Dimethicone, Ethylhexylglycerin, Fagara Zanthoxyloides Fruit Extract, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Leuconostoc/Radish Root Ferment Filtrate, Melia Azadirachta Leaf, Phenoxyethanol, Potassium Sorbate, Purified Water, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tocopheryl Acetate."
      ],
      "questions": [
        "Questions or comments? Call toll free 1-800-933-9344 or visit dermae.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 175 mL Tube Label THERAPEUTIC CLINICALLY TESTED Proven Clean Beauty™ DERMATOLOGIST • RECOMMENDED • DERMA • E Eczema Relief Lotion Neem, Burdock & Bearberry Extracts for dry skin symptoms associated with Psoriasis and Eczema 6 FL OZ / 175 mL PRINCIPAL DISPLAY PANEL - 175 mL Tube Label"
      ],
      "set_id": "767c4a76-8ccb-4530-9b4b-a7ea1a596c7f",
      "id": "eaae7d1f-5d16-4d75-a709-4131bae1f955",
      "effective_time": "20240618",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Derma E Eczema Relief"
        ],
        "generic_name": [
          "OATMEAL"
        ],
        "manufacturer_name": [
          "derma e"
        ],
        "product_ndc": [
          "54108-8712"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "240464"
        ],
        "spl_id": [
          "eaae7d1f-5d16-4d75-a709-4131bae1f955"
        ],
        "spl_set_id": [
          "767c4a76-8ccb-4530-9b4b-a7ea1a596c7f"
        ],
        "package_ndc": [
          "54108-8712-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0030985087123"
        ],
        "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"
        ]
      }
    }
  ]
}