{
  "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": [
    {
      "spl_product_data_elements": [
        "Evereden Healing Eczema Treatment Colloidal Oatmeal OCTYLDODECANOL SQUALANE SORBITAN OLIVATE CUCUMIS SATIVUS WHOLE ARGANIA SPINOSA SEED DIMETHICONE BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES 1,2-HEXANEDIOL HELIANTHUS ANNUUS SEED WAX COCOS NUCIFERA WHOLE SIMMONDSIA CHINENSIS SEED CERAMIDE AP TETRASODIUM GLUTAMATE DIACETATE ARGAN OIL SODIUM PYRROLIDONE CARBOXYLATE ALLANTOIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETEARYL OLIVATE OATMEAL OATMEAL GLYCERIN CERAMIDE NP ZINC OXIDE PHYTOSPHINGOSINE CHOLESTEROL SODIUM HYDROXIDE CETOSTEARYL ALCOHOL CERAMIDE 1 HYALURONATE SODIUM QUERCETIN HYDROXYPROLINE PROLINE PANTHENOL SODIUM LAUROYL LACTYLATE HYDROXYACETOPHENONE MENTHYL ETHYLAMIDO OXALATE SODIUM STEAROYL GLUTAMATE XANTHAN GUM"
      ],
      "statement_of_identity": [
        "Primary"
      ],
      "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 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": [
        "WARNINGS • 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(Aqua), Octyldodecanol, Glycerin, Dimethicone, Butyrospermum Parkii (Shea) Butter, Squalane, 1,2-Hexanediol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Cetearyl Olivate, Cetearyl Alcohol, Sorbitan Olivate, Simmondsia Chinensis (Jojoba) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Cocos Nucifera (Coconut) Oil, Spent Grain Wax, Argania Spinosa Kernel Oil, Ceramide AP, Ceramide EOP, Ceramide NP, Sodium PCA, Sodium Hyaluronate, Quercetin, Zinc Oxide, Hydroxyproline, Proline, Panthenol, Sodium Lauroyl Lactylate, Hydroxyacetophenone, Phytosphingosine, Menthyl Ethylamido Oxalate, Cholesterol, Tetrasodium Glutamate Diacetate, Sodium Stearoyl Glutamate, Xanthan Gum, Allantoin, Carbomer, Sodium Hydroxide"
      ],
      "package_label_principal_display_panel": [
        "Secondary"
      ],
      "set_id": "d43f0eaa-aab0-eaff-e053-2995a90ac5c8",
      "id": "292f57a8-bd3b-3a6b-e063-6294a90a8965",
      "effective_time": "20241213",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Evereden Healing Eczema Treatment"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Eden Brands, Inc."
        ],
        "product_ndc": [
          "72113-106"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "240651"
        ],
        "spl_id": [
          "292f57a8-bd3b-3a6b-e063-6294a90a8965"
        ],
        "spl_set_id": [
          "d43f0eaa-aab0-eaff-e053-2995a90ac5c8"
        ],
        "package_ndc": [
          "72113-106-03"
        ],
        "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"
        ]
      }
    }
  ]
}