{
  "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": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hydrocortisone Cream 1% Hydrocortisone Cream 1% with Aloe STEARYL ALCOHOL WHITE PETROLATUM TROLAMINE STEARIC ACID ALOE VERA LEAF CETOSTEARYL ALCOHOL METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE GLYCERYL MONOSTEARATE WATER HYDROCORTISONE HYDROCORTISONE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "DISTRIBUTED BY PUBLIX SUPER MARKETS, INC., 3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811 1-888-267-3037 publix.com Manufactured in India MH/DRUGS/28-KD/503"
      ],
      "active_ingredient": [
        "Active ingredient Hydrocortisone 1%"
      ],
      "purpose": [
        "Purpose Anti-itch"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves 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 temporarily relieves 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 in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor do not put directly into the rectum by using fingers or any mechanical device or applicator 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. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "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."
      ],
      "when_using": [
        "When using this product avoid contact with eyes do not use more than directed unless told to do so by a doctor 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"
      ],
      "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."
      ],
      "dosage_and_administration": [
        "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 do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal store at room temperature 68-77°F (20°-25°C) see crimp of tube or carton for Lot Number and Expiry Date"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aloe Vera Extract, Cetostearyl Alcohol, Glyceryl Monostearate SE, Kathon CG, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum"
      ],
      "questions": [
        "Questions or Comments? Call 1-888-267-3037"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 28.4 g Carton Carton"
      ],
      "set_id": "3c45a654-7fec-55b3-e063-6294a90a184b",
      "id": "4f59cc18-3120-8211-e063-6294a90ae91c",
      "effective_time": "20260413",
      "version": "2",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Hydrocortisone Cream 1%"
        ],
        "generic_name": [
          "HYDROCORTISONE CREAM 1% WITH ALOE"
        ],
        "manufacturer_name": [
          "Publix Super Markets Inc."
        ],
        "product_ndc": [
          "41415-330"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "106258"
        ],
        "spl_id": [
          "4f59cc18-3120-8211-e063-6294a90ae91c"
        ],
        "spl_set_id": [
          "3c45a654-7fec-55b3-e063-6294a90a184b"
        ],
        "package_ndc": [
          "41415-330-02"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}