{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "ECZEMA INTENSIVE DAILY RELIEF BODY colloidal oatmeal cream ETHYLHEXYLGLYCERIN TRISODIUM ETHYLENEDIAMINE DISUCCINATE AMYLOPECTIN, UNSPECIFIED SOURCE CERAMIDE NP CETYL STEARATE CHERIMOYA SODIUM DEHYDROACETATE PHYMATOLITHON CALCAREUM CERAMIDE AP SODIUM BENZOATE WATER GLYCERIN SQUALENE SUNFLOWER SEED SHEA BUTTER MACADAMIA SEED OIL GLYCERETH-8 ESTERS XANTHAN GUM ROSEMARY PHENYLPROPANOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE PROPANEDIOL LACTIC ACID CHOLESTEROL ACEGLUTAMIDE SODIUM LAUROYL LACTYLATE CAPRYLYL CAPRYLATE/CAPRATE RICE BRAN COCONUT OIL ALLANTOIN TOCOPHEROL SODIUM CITRATE PHYTOSPHINGOSINE POLYGLYCERYL-2 STEARATE CITRIC ACID MONOHYDRATE LECITHIN, SOYBEAN PENTYLENE GLYCOL STEARYL ALCOHOL CORN OIL PHENOXYETHANOL POTASSIUM SORBATE JOJOBA OIL PHYTOSTERYL MACADAMIATE SOY STEROL HYALURONATE SODIUM FOLIC ACID OATMEAL OATMEAL CAPRYLYL GLYCOL SUNFLOWER OIL GRAPE SEED OIL HEXAPEPTIDE-11 CERAMIDE 1 TRIHEPTANOIN GLYCERYL MONOSTEARATE"
      ],
      "active_ingredient": [
        "Colloidal Oatmeal 2%"
      ],
      "indications_and_usage": [
        "Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema. Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema."
      ],
      "recent_major_changes": [
        "Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema."
      ],
      "purpose": [
        "Skin protectant"
      ],
      "warnings": [
        "For external use only. When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water."
      ],
      "keep_out_of_reach_of_children": [
        "If swallowed get medical help or contact a poison control center right away."
      ],
      "stop_use": [
        "condition worsens symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "dosage_and_administration": [
        "Apply generously to affected areas.",
        "Apply generously to affected areas."
      ],
      "inactive_ingredient": [
        "Water/Eau/Aqua, Glycerin, Triheptanoin, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Cetyl Stearate, Caprylyl Caprylate/Caprate, Annona Cherimola Fruit Extract, Glyceryl Stearate, Jojoba Oil/Macadamia Seed Oil Esters, Stearyl Alcohol, Vegetable Oil/Huile Végétale, Helianthus Annuus (Sunflower) Seed Oil, Oryza Sativa (Rice) Bran Extract, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Helianthus Annuus (Sunflower) Extract, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Phytosteryl Macadamiate, Amylopectin, Phytosterols, Acetyl Glutamine, Lecithin, Lithothamnion Calcareum Extract, Hexapeptide-11, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Folic Acid, Oligopeptide-3, Oligopeptide-1, Oligopeptide-2, Lactic Acid, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Ceramide EOP, Xanthan Gum, Potassium Sorbate, Citric Acid, Trisodium Ethylenediamine Disuccinate, Ethylhexylglycerin, Tocopherol, Sodium Citrate, Propanediol, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Caprylyl Glycol, Sodium Lauroyl Lactylate, Sodium Benzoate, Carbomer, Phenoxyethanol."
      ],
      "questions": [
        "1.866.927.2783"
      ],
      "package_label_principal_display_panel": [
        "package label"
      ],
      "set_id": "0be3c631-bc9b-00a9-e063-6394a90abcbb",
      "id": "48339459-e0d7-1451-e063-6294a90ac093",
      "effective_time": "20260112",
      "version": "4",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "ECZEMA INTENSIVE DAILY RELIEF BODY"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL CREAM"
        ],
        "manufacturer_name": [
          "Skinfix, Inc."
        ],
        "product_ndc": [
          "61328-210"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "1189915"
        ],
        "spl_id": [
          "48339459-e0d7-1451-e063-6294a90ac093"
        ],
        "spl_set_id": [
          "0be3c631-bc9b-00a9-e063-6394a90abcbb"
        ],
        "package_ndc": [
          "61328-210-00"
        ],
        "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"
        ]
      }
    }
  ]
}