{
  "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": "2026-10-29",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Flexitol Face and Eyelid Eczema oatmeal oatmeal oatmeal Water Cetostearyl Alcohol GLYCERYL STEARATE SE Isopropyl Myristate DECYL OLEATE Glycerin BENZYL ALCOHOL SHEA BUTTER Caprylyl glycol Dehydroxanthan gum ALOE VERA LEAF"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "DISTRIBUTED BY: LaCorium Health USA Inc 801 Broad St, Suite 600 Chattanooga, TN 37402"
      ],
      "active_ingredient": [
        "Active ingredient Colloidal Oatmeal 5%"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema poison ivy, oak or sumac insect bites"
      ],
      "warnings": [
        "Warnings For external use only Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days When using this product do not get into eyes Do not use on broken skin Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "do_not_use": [
        "Do not use on broken skin"
      ],
      "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 apply generously to affected areas as needed"
      ],
      "storage_and_handling": [
        "Other Information Store between 50-86°F in a dry place"
      ],
      "inactive_ingredient": [
        "Inactive ingredients aloe barbadensis leaf juice powder, benzyl alcohol, butyrospermum parkii (shea) butter, caprylyl glycol, cetostearyl alcohol, decyl oleate, dehydroxanthan gum, glycerin, glyceryl stearate se, isopropyl myristate, water"
      ],
      "questions": [
        "Questions or Comments? Call Toll Free 1-866-478-3338 usainfo@flexitol.com www.flexitol.com"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 40 g Tube Carton NDC: 43251-4904-1 Flexitol™ SKIN THERAPY FACE & EYELID ECZEMA CREAM SOOTHING RELIEF FOR DELICATE SKIN CLINICALLY TESTED* Helps relieve red, itchy eczema rashes on face and eyelids With soothing Colloidal Oatmeal 5% Free from cortisone Award winning formula Skin protectant Hypoallergenic Net Wt. 1.4 oz (40g) PRINCIPAL DISPLAY PANEL - 40 g Tube Carton"
      ],
      "set_id": "f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65",
      "id": "daa3258e-623a-4eb1-adae-94b38d034006",
      "effective_time": "20251202",
      "version": "4",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Flexitol Face and Eyelid Eczema"
        ],
        "generic_name": [
          "OATMEAL"
        ],
        "manufacturer_name": [
          "LaCorium Health USA Inc."
        ],
        "product_ndc": [
          "43251-4904"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OATMEAL"
        ],
        "rxcui": [
          "1595494"
        ],
        "spl_id": [
          "daa3258e-623a-4eb1-adae-94b38d034006"
        ],
        "spl_set_id": [
          "f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65"
        ],
        "package_ndc": [
          "43251-4904-1"
        ],
        "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"
        ]
      }
    }
  ]
}