{
  "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": "2026-05-12",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Hydrocortisone Anti-pruritic WATER HYDROCORTISONE HYDROCORTISONE CETOSTEARYL ALCOHOL PROPYLENE GLYCOL PETROLATUM STEARIC ACID GLYCERYL STEARATE SE METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE TROLAMINE"
      ],
      "active_ingredient": [
        "Active Ingredient Hydrocortisone USP 1%"
      ],
      "purpose": [
        "Purpose Antipruritic (Anti-Itch)"
      ],
      "indications_and_usage": [
        "Uses For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and for external genital, feminine, and anal itching. Other uses of this product should only be under the advice and supervision of a doctor."
      ],
      "warnings": [
        "Warnings For external use only If pregnant or breast-feeding, ask a health professional before use. Do not use in the eyes for diaper rash for external genital or feminine itching if you have a vaginal discharge more than the recommended daily dosage unless directed by a doctor this product in the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer than 7 days. bleeding occurs near anus when used for anal itching If swallowed, get medical help or contact a Poison Control Center (1-888-222-1222) right away."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "do_not_use": [
        "Do not use in the eyes for diaper rash for external genital or feminine itching if you have a vaginal discharge more than the recommended daily dosage unless directed by a doctor this product in the rectum by using fingers or any mechanical device or applicator"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer than 7 days. bleeding occurs near anus when used for anal itching"
      ],
      "keep_out_of_reach_of_children": [
        "If swallowed, get medical help or contact a Poison Control Center (1-888-222-1222) 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: consult a doctor. When used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Children under 12: consult a doctor before using for anal itching."
      ],
      "storage_and_handling": [
        "Other Information Store at room temperature"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Cetostearyl Alcohol, Glyceryl Palmitostearate, Kathon, Petrolatum, Propylene Glycol, Stearic Acid, Tea Leaf, Water"
      ],
      "questions": [
        "Questions and Comments? 1-888-396-2739"
      ],
      "package_label_principal_display_panel": [
        "Label PDP CR-1139 Hydrocortisone Cream PDP"
      ],
      "set_id": "8b3af210-3097-8c10-e053-2a95a90a86f1",
      "id": "44710f88-baec-2420-e063-6394a90aa6bc",
      "effective_time": "20251125",
      "version": "9",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Hydrocortisone"
        ],
        "generic_name": [
          "ANTI-PRURITIC"
        ],
        "manufacturer_name": [
          "Cardinal Health"
        ],
        "product_ndc": [
          "70000-0485"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "106258"
        ],
        "spl_id": [
          "44710f88-baec-2420-e063-6394a90aa6bc"
        ],
        "spl_set_id": [
          "8b3af210-3097-8c10-e053-2a95a90a86f1"
        ],
        "package_ndc": [
          "70000-0485-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}