{
  "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 Intensive Eczema Balm Colloidal Oatmeal POLYHYDROXYSTEARIC ACID (2300 MW) CANDELILLA WAX RIBES NIGRUM SEED OIL LECITHIN, SUNFLOWER PHAEODACTYLUM TRICORNUTUM HELIANTHUS ANNUUS SEED WAX OCTYLDODECANOL ISOSTEARYL ALCOHOL SUNFLOWER OIL UNSAPONIFIABLES OATMEAL OATMEAL POLYGLYCERYL-4 ISOSTEARATE WATER C18-38 ALKYL HYDROXYSTEAROYL STEARATE .BETA.-SITOSTEROL INDIAN FRANKINCENSE TOCOPHEROL CERAMIDE NP ROSEMARY SUNFLOWER OIL JOJOBA OIL SQUALANE CARDIOSPERMUM HALICACABUM LEAF CORN OIL MEDIUM-CHAIN TRIGLYCERIDES JOJOBA BUTTER SHEA BUTTER ARGAN OIL OLEIC ACID LINOLEIC ACID OMEGA-3 FATTY ACIDS GLYCERYL DIBEHENATE POLYGLYCERYL-3 DIISOSTEARATE CERAMIDE NG QUERCETIN PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE COCONUT OIL"
      ],
      "statement_of_identity": [
        "Eczema Balm Jar"
      ],
      "active_ingredient": [
        "Colloidal Oatmeal 2%"
      ],
      "purpose": [
        "Skin Protectant"
      ],
      "indications_and_usage": [
        "USES: Temporarily protects and helps relieve minor skin irritation and itching due to: Eczema Rashes"
      ],
      "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: 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: Use as needed."
      ],
      "other_safety_information": [
        "Other Information: Store product at room temperature"
      ],
      "inactive_ingredient": [
        "Helianthus Annuus (Sunflower) Seed Oil, C18-38 Alkyl Hydroxystearoyl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Vegetable Oil, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Butter, Octyldodecanol, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Spent Grain Wax, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Phaeodactylum Tricornutum Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Argania Spinosa Kernel Oil, Hydrogenated Vegetable Oil, Beta-Sitosterol, Boswellia Serrata Gum, Oleic Acid, Linoleic Acid, Phytosterols, Phospholipids, Glyceryl Behenate, Saccharomyces/Zinc Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Iron Ferment, Saccharomyces/Silicon Ferment, Saccharomyces/Copper Ferment, Polyglyceryl-4 Isostearate, Lecithin, Polyglyceryl-3 Diisostearate, Ceramide NG, Ceramide NP, Water (Aqua), Rosmarinus Officinalis (Rosemary) Leaf Extract, Quercetin, Tocopherol"
      ],
      "package_label_principal_display_panel": [
        "Eczema Balm Carton"
      ],
      "set_id": "2243d4ca-5ca4-54d0-e063-6394a90a3940",
      "id": "2243d4ca-5ca5-54d0-e063-6394a90a3940",
      "effective_time": "20240916",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Evereden Intensive Eczema Balm"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Eden Brands Inc."
        ],
        "product_ndc": [
          "72113-109"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "1486142"
        ],
        "spl_id": [
          "2243d4ca-5ca5-54d0-e063-6394a90a3940"
        ],
        "spl_set_id": [
          "2243d4ca-5ca4-54d0-e063-6394a90a3940"
        ],
        "package_ndc": [
          "72113-109-21"
        ],
        "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"
        ]
      }
    }
  ]
}