{
  "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 Antipruritic (Anti-Itch) PROPYLENE GLYCOL METHYLCHLOROISOTHIAZOLINONE WHITE PETROLATUM STEARIC ACID TROLAMINE GLYCERYL STEARATE SE HYDROCORTISONE HYDROCORTISONE WATER CETOSTEARYL ALCOHOL"
      ],
      "active_ingredient": [
        "Active Ingredients Hydrocortisone USP 1%"
      ],
      "purpose": [
        "Purpose Antipruritic (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 sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching."
      ],
      "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 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 for 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 due to anal itching Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 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 for 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 due to anal itching"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 by 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 15º-30ºC (59º-86ºF) Avoid excessive heat Tamper Evident. Do not use if seal is damaged."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Petrolateum"
      ],
      "package_label_principal_display_panel": [
        "Label 1137 BX MASTER",
        "Label 1139 BX MASTER",
        "Label 1137UB-6 1137UB-6 1137UB-6_BX_MASTER",
        "Label 1137-25 1137-25 1137-25 BX_MASTER"
      ],
      "set_id": "81dff9df-6f7e-49f0-e053-2a91aa0af7e7",
      "id": "0fa32e68-a566-6d7e-e063-6394a90af08b",
      "effective_time": "20240123",
      "version": "6",
      "openfda": {
        "application_number": [
          "M032"
        ],
        "brand_name": [
          "Hydrocortisone"
        ],
        "generic_name": [
          "ANTIPRURITIC (ANTI-ITCH)"
        ],
        "manufacturer_name": [
          "Dynarex Corporation"
        ],
        "product_ndc": [
          "67777-004"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "106258"
        ],
        "spl_id": [
          "0fa32e68-a566-6d7e-e063-6394a90af08b"
        ],
        "spl_set_id": [
          "81dff9df-6f7e-49f0-e053-2a91aa0af7e7"
        ],
        "package_ndc": [
          "67777-004-03",
          "67777-004-04",
          "67777-004-02",
          "67777-004-01",
          "67777-004-06",
          "67777-004-05",
          "67777-004-08",
          "67777-004-07"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0616784113920",
          "0616784113722",
          "0840117328174",
          "0840117328198"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}