{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Cooling Itch Relief Cooling Itch Relief HYDROCORTISONE HYDROCORTISONE GLYCERIN"
      ],
      "active_ingredient": [
        "OTC Active Ingredient Section Hydrocortisone 1% Anti itch Principal Display Panel Anti Itch Spray.jpg"
      ],
      "purpose": [
        "USES Temporarily relieves itching associated with minorskin irritation and rashes due to:• eczema • poison ivy, oak and sumac • cosmetics• psoriasis • soaps and detergents • jewelry• insect bites • seborrheic dermatitis"
      ],
      "warnings": [
        "WARNINGS For external use only"
      ],
      "do_not_use": [
        "DO NOT USE • in or near the eyes • for external genital • vaginal or anal itching • for diaper rash: ask a doctor"
      ],
      "when_using": [
        "WHEN USING THIS PRODUCT • Keep out of eyes. Rinse with water to remove • Use only as directed. • Do not puncture or incinerate. Contents under pressure• Do not store at temperature above 120F"
      ],
      "stop_use": [
        "STOP USE AND ASK A DOCTOR IF • condition worsens or does not improve withing 7 days• symptomspersist more than 7 days or clear up and occur again within a few days"
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF THE CHILDREN If swallowed, get medical help or contact a Poison Control Center right away",
        "OTC - Keep Out of Reach of Children Keep out of reach of the children If swallowed, get medical help or contact a Poison Control Center right away"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENT Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, Water"
      ],
      "dosage_and_administration": [
        "Dosage and Administration See Attached Image File Principal Display Panel Anti Itch Spray"
      ],
      "indications_and_usage": [
        "Indication & Usage For the temporary relief of itching associated with minor skin irritation and rashes due to: • eczema • poison ivy, oak and sumac • cosmetics • jewelry • soaps and detergents • insect bites. Other uses of this product should be only under the advice and supervision of a doctor. Warnings For external use only. Flammable: Keep away from fire or flame Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor. Do not use for the treatment of diaper rash. Consult a doctor. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F"
      ],
      "package_label_principal_display_panel": [
        "Anti-Itch Spray Anti-Itch Spray"
      ],
      "set_id": "a24bdea0-18e8-8a5e-e053-2995a90acea2",
      "id": "0eb11e53-062d-3f3d-e063-6294a90a7e75",
      "effective_time": "20240111",
      "version": "7",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Cooling Itch Relief"
        ],
        "generic_name": [
          "COOLING ITCH RELIEF"
        ],
        "manufacturer_name": [
          "NeilMed Pharmaceuticals, Inc"
        ],
        "product_ndc": [
          "13709-310"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "317564"
        ],
        "spl_id": [
          "0eb11e53-062d-3f3d-e063-6294a90a7e75"
        ],
        "spl_set_id": [
          "a24bdea0-18e8-8a5e-e053-2995a90acea2"
        ],
        "package_ndc": [
          "13709-310-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0311917206462"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}