{
  "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": "2026-10-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Quality Choice Hydrocortisone POLYSORBATE 60 MATRICARIA CHAMOMILLA FLOWERING TOP PETROLATUM GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) WATER STEARYL ALCOHOL PROPYLENE GLYCOL STEARETH-21 METHYL GLUCETH-20 DIMETHICONE 350 EDETATE DISODIUM PROPYLPARABEN CETYL ALCOHOL GLYCERIN GLYCERYL STEARATE/PEG-100 STEARATE MAGNESIUM ASCORBYL PHOSPHATE MENTHYL LACTATE METHYLPARABEN STEARETH-2 VITAMIN A PALMITATE ALOE VERA LEAF ALPHA-TOCOPHEROL ACETATE BENZYL ALCOHOL HYDROCORTISONE HYDROCORTISONE"
      ],
      "active_ingredient": [
        "Active ingredient Purpose Hydrocortisone 1%...................................Anti-itch"
      ],
      "purpose": [
        "Uses temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema, psoriasis, jewelry, insect bites, soaps, cosmetics, detergents, seborrheic dermatitis, poison icy, oak, sumac temporary relieves external anal and genital itching other uses of this product should only be 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 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 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"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "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."
      ],
      "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 tissue or a soft cloth before applying apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information store at room temperature 20-25°C (68-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients aloe vera leaf, alpha-tocopherol acetate, benzyl alcohol, cetyl alcohol, dimethicone 350, edetate disodium, gelatin hydrolysate, glycerin, glyceryl stearate/peg-100 stearate, magnesium ascorbyl phosphate, matricaria chamomilla flowering top, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, steareth-2, steareth-21, stearyl alcohol, vitamin a palmitate"
      ],
      "dosage_and_administration": [
        "Distributed by CDMA, Inc. Novi, MI 48375 Made in China"
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "99198.1"
      ],
      "set_id": "24c3eb99-92ac-658c-e063-6394a90ab51f",
      "id": "414ecbdc-6fe0-4812-e063-6394a90a4b7b",
      "effective_time": "20251016",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Quality Choice"
        ],
        "generic_name": [
          "HYDROCORTISONE"
        ],
        "manufacturer_name": [
          "Chain Drug Marketing Association, Inc."
        ],
        "product_ndc": [
          "83324-297"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "106258"
        ],
        "spl_id": [
          "414ecbdc-6fe0-4812-e063-6394a90a4b7b"
        ],
        "spl_set_id": [
          "24c3eb99-92ac-658c-e063-6394a90ab51f"
        ],
        "package_ndc": [
          "83324-297-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}