{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "BIA Eczema Relief Oatmeal Oatmeal Oatmeal WATER SUNFLOWER OIL PROPANEDIOL GLYCERYL MONOSTEARATE GLYCERIN LACTOBACILLUS ACIDOPHILUS C13-15 ALKANE CETYL ALCOHOL CALENDULA OFFICINALIS WHOLE PADINA PAVONICA BETASIZOFIRAN COMFREY LEAF COCONUT SODIUM BENZOATE HABERLEA RHODOPENSIS LEAF POTASSIUM SORBATE ANHYDROUS CITRIC ACID CEDRUS DEODARA WOOD OIL PHYTATE SODIUM XANTHAN GUM HYALURONATE SODIUM SHEA BUTTER CERAMIDE NP MORINGA OLEIFERA SEED OIL PHYTOSPHINGOSINE MEADOWFOAM SEED OIL MACADAMIA OIL HYDROGENATED SOYBEAN LECITHIN"
      ],
      "active_ingredient": [
        "Active ingredient Colloidal Oatmeal 1%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Use Temporarily protects and helps relieve minor skin irritation due to eczema rashes"
      ],
      "warnings": [
        "Warnings For external use only. When using this product do not get into eyes stop use and consult a doctor if condition worsens or symptoms last more than seven 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 consult a doctor if condition worsens or symptoms last more than seven 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 Use as needed."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Water (Aqua), Helianthus Annuus (Sunflower) Seed Oil, Propanediol, Glyceryl Stearate, Glycerin, Lactobacillus Ferment, C13-15 Alkane, Cetyl Alcohol, Lactobacillus, Calendula Officinalis Meristem Cell Extract, Haberlea Rhodopensis Leaf Extract, Padina Pavonica Thallus Extract, Symphytum Officinale (Comfrey) Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Butyrospermum Parkii (Shea) Butter, Moringa Oleifera Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Macadamia Integrifolia Seed Oil, Cedrus Deodara (Cedarwood) Wood Oil, Hydrogenated Lecithin, Phytosphingosine, Hydrolyzed Sodium Hyaluronate, Ceramide NP, Sodium Phytate, Sclerotium Gum, Xanthan Gum, Sodium Benzoate, Potassium Sorbate, Citric Acid"
      ],
      "questions": [
        "Questions? Email support@codexlabscorp.com or call 1-855-263-3980 Steroid Free Microbiome Friendly"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel – 100 mL Carton Label CODEX LABS ™ BIA ECZEMA RELIEF LOTION Skin Protectant Colloidal Oatmeal 1% 3.4 FL. OZ. / 100 mL ℮ Principal Display Panel – 100 mL Carton Label"
      ],
      "set_id": "2f2de819-b7db-4c1e-9d6e-9ce33f7e6d05",
      "id": "b35e3243-0d62-48a5-b64d-046ccaa272ce",
      "effective_time": "20250127",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "BIA Eczema Relief"
        ],
        "generic_name": [
          "OATMEAL"
        ],
        "manufacturer_name": [
          "Codex Labs Corporation"
        ],
        "product_ndc": [
          "83196-582"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "spl_id": [
          "b35e3243-0d62-48a5-b64d-046ccaa272ce"
        ],
        "spl_set_id": [
          "2f2de819-b7db-4c1e-9d6e-9ce33f7e6d05"
        ],
        "package_ndc": [
          "83196-582-10"
        ],
        "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"
        ]
      }
    }
  ]
}