{
  "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,
      "limit": 1,
      "total": 18
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hydrocortisone Anti Itch HYDROCORTISONE HYDROCORTISONE MINERAL OIL PETROLATUM"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredients 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 sumac 􀁑 soaps 􀁑 jewelry 􀁑 detergents 􀁑 cosmetics 􀁑 psoriasis 􀁑 seborrheic dermatitis 􀁑 for external genital, feminine and anal itching 􀁑 other uses of this product should be only under the advice and supervision of a doctor"
      ],
      "warnings": [
        "Warnings: For external use only. 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": [
        "Warnings: 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 a doctor if : Stop use and ask a 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. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222"
      ],
      "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 If pregnant or breast-feeding 􀁑 ask a health professional before use. 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 Children under 12 years of age: consult a doctor"
      ],
      "storage_and_handling": [
        "Storage temperature: not to exceed 30°C (86°F)."
      ],
      "other_safety_information": [
        "Other information Before using any medication, read all label directions. Keep carton, it contains important information."
      ],
      "inactive_ingredient": [
        "Inactive ingredients mineral oil, white petrolatum."
      ],
      "safe_handling_warning": [
        "TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING"
      ],
      "package_label_principal_display_panel": [
        "Hydrocortisone Ointment"
      ],
      "set_id": "031957e1-9b0c-1579-e063-6394a90aaee8",
      "id": "1ce22733-8f6f-d7ea-e063-6294a90aa49b",
      "effective_time": "20240710",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Hydrocortisone"
        ],
        "generic_name": [
          "ANTI ITCH"
        ],
        "manufacturer_name": [
          "NeilMed Pharmaceuticals Inc"
        ],
        "product_ndc": [
          "13709-316"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "spl_id": [
          "1ce22733-8f6f-d7ea-e063-6294a90aa49b"
        ],
        "spl_set_id": [
          "031957e1-9b0c-1579-e063-6394a90aaee8"
        ],
        "package_ndc": [
          "13709-316-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0705928150010"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}