{
  "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": [
        "RoyceDerm Eczema Relief Cream Colloidal Oatmeal 1% AQUA GLYCERIN BUTYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE, D- BUTYROSPERMUM PARKII (SHEA) BUTTER HYDROXYACETOPHENONE ASIATICOSIDE ALOE BARBADENSIS LEAF CHRYSANTHELLUM INDICUM TOP ECTOIN MALTODEXTRIN CETEARYL GLUCOSIDE PANTHENOL HOUTTUYNIA CORDATA FLOWERING TOP CENTELLA ASIATICA TRITERPENOIDS OAT OATMEAL OATMEAL N-CARBOXYMETHYLCHITOSAN CERAMIDE 6 II PURSLANE PAEONIA SUFFRUTICOSA ROOT SODIUM POLYGLUTAMATE (200000 MW) MADECASSOSIDE CAMELLIA SINENSIS LEAF SODIUM HYALURONATE CETEARYL ALCOHOL SQUALANE CAMELLIA JAPONICA SEED OIL SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL OPUNTIA STREPTACANTHA STEM 1,2-HEXANEDIOL CERAMIDE 1 TREMELLA FUCIFORMIS WHOLE SCUTELLARIA BAICALENSIS ROOT ALLANTOIN CERAMIDE 3"
      ],
      "active_ingredient": [
        "Colloidal Oatmeal 1%"
      ],
      "purpose": [
        "Skin Protectant"
      ],
      "dosage_and_administration": [
        "Temporarily protects and helps relieve minor skin irritationand itching due to Eczema and Rashes"
      ],
      "warnings": [
        "For external use only do not get into eyes condition worsens or symptoms last morethan 7 days or clear up and occur again within a few days In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Centerright away.(1-800-222-1222)"
      ],
      "when_using": [
        "do not get into eyes"
      ],
      "ask_doctor": [
        "condition worsens or symptoms last morethan 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Centerright away.(1-800-222-1222)"
      ],
      "indications_and_usage": [
        "Conduct a patch test on a small area of skin to checkfor sensitivity or allergic reaction. Apply as needed to affectedarea. Use 1-2 times daily or as directed by a doctor. For childrenunder 6 months of age: ask a doctor."
      ],
      "other_safety_information": [
        "store at room temperature. Avoid excessive heat and direct sunlight."
      ],
      "inactive_ingredient": [
        "Aqua, Butylene Glycol, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Camellia Japonica Seed Oil,Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate, Cetearyl Glucoside, Panthenol, 1,2-Hexanediol, Hydroxyacetophenone, Ceramide 1, Ceramide 3, Ceramide 6 ll, Ectoin,Carboxymethyl Chitosan, Camellia Sinensis Leaf Extract, Tremella Fuciformis Polysaccharide, Avena Sativa (Oat) Kernel Extract, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Maltodex-trin, Chrysanthellum Indicum Extract, Houttuynia Cordata ExtractOpuntia Streptacantha Stem Extract, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Allantoin, Sodium Hyaluronate, Sodium Polyglutamate, Centella Asiatica Extract, Madecassoside, Asiaticoside"
      ],
      "questions": [
        "Email service@roycederm.com"
      ],
      "package_label_principal_display_panel": [
        "package"
      ],
      "set_id": "3e09f000-01d2-0d21-e063-6294a90ac548",
      "id": "3e09f000-01d3-0d21-e063-6294a90ac548",
      "effective_time": "20250905",
      "version": "1",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "RoyceDerm Eczema Relief Cream"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL 1%"
        ],
        "manufacturer_name": [
          "RoyceDerm LLC"
        ],
        "product_ndc": [
          "85424-010"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "240651"
        ],
        "spl_id": [
          "3e09f000-01d3-0d21-e063-6294a90ac548"
        ],
        "spl_set_id": [
          "3e09f000-01d2-0d21-e063-6294a90ac548"
        ],
        "package_ndc": [
          "85424-010-01"
        ],
        "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"
        ]
      }
    }
  ]
}