{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "CVS Cools Itch Fast Hydrocortisone ALOE VERA LEAF CARBOXYPOLYMETHYLENE GLYCERIN METHYLPARABEN OAT KERNEL OIL PROPYLENE GLYCOL SODIUM HYDROXIDE SORBITAN MONOSTEARATE STEARYL ALCOHOL WHITE WAX WATER HYDROCORTISONE HYDROCORTISONE PROPYLPARABEN"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Hydrocortisone 1%......................... Anti-itch"
      ],
      "purpose": [
        "Uses for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema insect bites poison ivy posion oak poison sumac soaps jewlery detergents cosmetics psoriasis seborrheic dematitis temporarily relievs external anal and genital 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": [
        "Do not use in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. more than directed unless directed by a doctor"
      ],
      "when_using": [
        "When using this product avoid contact with the eyes do not put directly 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 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 asked a doctor rectal bleeding occurs"
      ],
      "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.",
        "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."
      ],
      "indications_and_usage": [
        "Directions for itching of skin irritation, inflammation, and rashes: 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: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissure or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor"
      ],
      "storage_and_handling": [
        "Other information store at room temperature 20-25°C (68-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients aloe vera leaf, carboxypolymethylene, glycerin, methylparaben, oat kernel oil, propylene glycol, propylparaben, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol, water, white wax"
      ],
      "dosage_and_administration": [
        "DISTRIBUTED BY: ONE CVS DRIVE WOONSOCKET, RI 02895 USA"
      ],
      "package_label_principal_display_panel": [
        "28397"
      ],
      "set_id": "8a4544df-bbba-47d2-ada0-352757abc91f",
      "id": "4253413e-385c-63ad-e063-6294a90ae488",
      "effective_time": "20251029",
      "version": "13",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "CVS Cools Itch Fast"
        ],
        "generic_name": [
          "HYDROCORTISONE"
        ],
        "manufacturer_name": [
          "CVS Pharmacy, Inc."
        ],
        "product_ndc": [
          "59779-729"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "198706"
        ],
        "spl_id": [
          "4253413e-385c-63ad-e063-6294a90ae488"
        ],
        "spl_set_id": [
          "8a4544df-bbba-47d2-ada0-352757abc91f"
        ],
        "package_ndc": [
          "59779-729-28"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0050428283974"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}