{
  "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": "2026-08-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hydrocortisone Drs. Hydrocortisone HYDROCORTISONE HYDROCORTISONE CETEARETH-12 PROPYLENE GLYCOL METHYLPARABEN EDETATE DISODIUM TROLAMINE SODIUM CETOSTEARYL SULFATE PROPYLPARABEN WATER CETOSTEARYL ALCOHOL MINERAL OIL .ALPHA.-TOCOPHEROL STEARIC ACID"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Hydrocortisone, USP 1%"
      ],
      "purpose": [
        "PURPOSE Anti-itch"
      ],
      "indications_and_usage": [
        "USES for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: •eczema •insect bites •poison ivy •poison oak •poison ..."
      ],
      "warnings": [
        "WARNINGS For external use only"
      ],
      "do_not_use": [
        "DO NOT USE for external feminine itching if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor."
      ],
      "when_using": [
        "WHEN USING THIS PRODUCT •avoid contact with the eyes •do not begin the use of any other hydrocortisone product unless directed by a doctor •for external anal itching : do not use more than directed unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator"
      ],
      "stop_use": [
        "STOP USE AND ASK YOUR DOCTOR IF •symptoms last for more than 7 days •the condition gets worse •symptoms clear up and occur again in a few days •rectal bleeding occurs, consult doctor promptly"
      ],
      "keep_out_of_reach_of_children": [
        "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 Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: do not use, consult a doctor For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product"
      ],
      "other_safety_information": [
        "OTHER INFORMATION Store at room temperature 59°-86°F (15°-30°C). Protect from freezing. Before using any medication, read all label directions. Keep carton, it contains important information."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil , propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E"
      ],
      "package_label_principal_display_panel": [
        "original strenghth fast itch relief cream hydrocortisone"
      ],
      "set_id": "b0eac8f3-bb80-6563-e053-2995a90a83c9",
      "id": "48fe7e3f-613b-4f28-e063-6294a90aa4e0",
      "effective_time": "20260122",
      "version": "6",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Hydrocortisone"
        ],
        "generic_name": [
          "DRS. HYDROCORTISONE"
        ],
        "manufacturer_name": [
          "OL PHARMA TECH,LLC"
        ],
        "product_ndc": [
          "80489-001"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "106258"
        ],
        "spl_id": [
          "48fe7e3f-613b-4f28-e063-6294a90aa4e0"
        ],
        "spl_set_id": [
          "b0eac8f3-bb80-6563-e053-2995a90a83c9"
        ],
        "package_ndc": [
          "80489-001-01",
          "80489-001-02"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}