{
  "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": 4
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hydrocortisone Hydrocortisone Spray ALCOHOL HYDROCORTISONE HYDROCORTISONE WATER GLYCERIN POLYETHYLENE GLYCOL 400 DIETHYLENE GLYCOL MONOETHYL ETHER MENTHYL LACTATE METHYL GLUCETH-20 OAT PROPANEDIOL SODIUM CITRATE CITRIC ACID"
      ],
      "active_ingredient": [
        "Active ingredient Hydrocortisone 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 detergents cosmetics jewelry seborrheic dermatitis psoriasis other uses of this product should be only under the advice and supervision of a doctor"
      ],
      "warnings": [
        "Warnings For external use only. Flammable: Keep away from fire or flame. Do not use for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have consulted a doctor Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "safe_handling_warning": [
        "Flammable: Keep away from fire or flame."
      ],
      "do_not_use": [
        "Do not use for the treatment of diaper rash. Consult a doctor."
      ],
      "when_using": [
        "When using this product avoid contact with the eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have consulted a doctor"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the 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: spray affected area not more than 3 to 4 times daily children under 2 years of age: do not use, consult a doctor"
      ],
      "information_for_patients": [
        "Other Information store at 20 o to 25 o C (68 o to 77 o F) shake well before use pump must be primed before use"
      ],
      "inactive_ingredient": [
        "Inactive ingredients SD ALCOHOL 40-B, WATER, GLYCERIN, PEG-8, ETHOXYDIGLYCOL, MENTHYL LACTATE, METHYL GLUCETH-20, AVENA SATIVA (OAT) KERNEL EXTRACT, PROPANEDIOL, SODIUM CITRATE, CITRIC ACID."
      ],
      "questions": [
        "Questions ? Call 1-866-964-0939"
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel MAXIMUM STRENGTH Hydrocortisone 1%/ Anti-Itch Spray COMPARE TO CORTIZONE-10 ACTIVE INGREDIENT RELIEVES ITCHING FROM MINOR SKIN IRRITATION & RASHES DUE TO INSECT BITES & POSION IVY, OAK & SUMAC Ozone-Friendly, Non-Aerosol Calms Irritated Skin No-Touch & No-Mess Shake Well 2.5 FL. 0Z. (74 mL) meijer label"
      ],
      "set_id": "28daaf97-b0b3-7a54-e063-6294a90a23f1",
      "id": "4266004b-0572-266d-e063-6394a90a83b0",
      "effective_time": "20251030",
      "version": "2",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Hydrocortisone"
        ],
        "generic_name": [
          "HYDROCORTISONE SPRAY"
        ],
        "manufacturer_name": [
          "Meijer Distribution Inc."
        ],
        "product_ndc": [
          "79481-9967"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "317564"
        ],
        "spl_id": [
          "4266004b-0572-266d-e063-6394a90a83b0"
        ],
        "spl_set_id": [
          "28daaf97-b0b3-7a54-e063-6294a90a23f1"
        ],
        "package_ndc": [
          "79481-9967-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}