{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "TCX Skincare Colloidal Oatmeal OATMEAL OATMEAL WATER GLYCERIN CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) CETYL PALMITATE MINERAL OIL MEDIUM-CHAIN TRIGLYCERIDES CETYL ALCOHOL GLYCERYL 1-STEARATE DIMETHICONE, UNSPECIFIED PEG-40 MONOSTEARATE SODIUM HYDROXIDE PHENOXYETHANOL DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE OCTYLDODECANOL"
      ],
      "active_ingredient": [
        "Active Ingredient Colloidal Oatmeal 2%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses • Temporarily protects and helps relieve minor skin irritation and itching due to dry skin and eczema"
      ],
      "warnings": [
        "Warnings • For external use only Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product: • Do not get into eyes • Stop use and ask doctor if condition worsens"
      ],
      "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."
      ],
      "when_using": [
        "When using this product: • Do not get into eyes • Stop use and ask doctor if condition worsens"
      ],
      "dosage_and_administration": [
        "Directions • Apply to affected areas of skin twice daily"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Cetyl Palmitate, Dimethicone, DMDM Hydantoin, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Mineral Oil, Octyldodecanol, PEG-40 Stearate, Phenoxy Ethanol, Sodium Hydroxide, Water"
      ],
      "package_label_principal_display_panel": [
        "Package/Label Principal Display Panel - Carton Label ECZEMA AND DRY SKIN RELIEF Skin Protectant tcx skincare ® UNIQUE HYDROMIMETICS ™ 2 fl oz/59 mL Carton Label image-01",
        "Package/Label Principal Display Panel - Sample Label tcx skincare ® UNIQUE HYDROMIMETICS ™ 0.3 oz Eczema and Dry Skin Relief Skin Protectant Directions: Apply to affected areas of skin twice daily SAMPLE NOT FOR RESALE tcxskincare.com Sample Label image-02"
      ],
      "set_id": "c3be950b-28cf-47c2-9570-ebd46e43b1ba",
      "id": "600612eb-7f2c-42b7-8b2a-6eb01342aa66",
      "effective_time": "20251224",
      "version": "6",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "TCX Skincare"
        ],
        "generic_name": [
          "COLLOIDAL OATMEAL"
        ],
        "manufacturer_name": [
          "Theraceutix, LLC"
        ],
        "product_ndc": [
          "49449-100"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "1189915"
        ],
        "spl_id": [
          "600612eb-7f2c-42b7-8b2a-6eb01342aa66"
        ],
        "spl_set_id": [
          "c3be950b-28cf-47c2-9570-ebd46e43b1ba"
        ],
        "package_ndc": [
          "49449-100-01",
          "49449-100-02"
        ],
        "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"
        ]
      }
    }
  ]
}