{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Hydrocortisone with aloe hydrocortisone with Aloe Anti Itch ALOE VERA LEAF BENZYL ALCOHOL ISOPROPYL MYRISTATE METHYLPARABEN WATER POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL ISOSTEARYL NEOPENTANOATE PEG-40 MONOSTEARATE CETYL PALMITATE GLYCERIN HYDROCORTISONE HYDROCORTISONE"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredients Hydrocortisone, USP 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 ■ jewelry ■ detergents ■ cosmetics ■ psoriasis ■ seborrheic dermatitis ■ for external genital, feminine and anal 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 ■ for external feminine itching 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 the eyes ■ do not begin the use of any other hydrocortisone product unless directed by a doctor ■ for external anal itching: ■ do not use more than directed unless directed by a doctor ■ do not put this product into the rectum by using fingers or any mechanical device or applicator."
      ],
      "stop_use": [
        "Stop use and ask a doctor if ■ symptoms last for more than 7 days. ■ the condition gets worse ■ symptoms clear up and occur again in a few days ■ rectal bleeding occurs, consult doctor promptly."
      ],
      "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. 1-800-222-1222"
      ],
      "dosage_and_administration": [
        "Directions 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 ■ do not use, consult a doctor If pregnant or breast-feeding ■ ask a health professional before use. For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of age: consult a doctor"
      ],
      "storage_and_handling": [
        "Other information: ■ Storage temperature: not to exceed 30°C (86°F). Protect from freezing. ■ Before using any medication, read all label directions. Keep carton, it contains important information."
      ],
      "recent_major_changes": [
        ""
      ],
      "inactive_ingredient": [
        "Inactive ingredients: Aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alchol, cetyl palmitate, glyceryl, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH."
      ],
      "safe_handling_warning": [
        "TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING"
      ],
      "package_label_principal_display_panel": [
        "Hydrocream 1%",
        "1oz"
      ],
      "set_id": "032b9f58-5f64-04dd-e063-6294a90a6bb9",
      "id": "1ce25285-5f43-da63-e063-6394a90ab690",
      "effective_time": "20240710",
      "version": "4",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Hydrocortisone with aloe"
        ],
        "generic_name": [
          "HYDROCORTISONE WITH ALOE ANTI ITCH"
        ],
        "manufacturer_name": [
          "NeilMed Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "13709-317"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "spl_id": [
          "1ce25285-5f43-da63-e063-6394a90ab690"
        ],
        "spl_set_id": [
          "032b9f58-5f64-04dd-e063-6294a90a6bb9"
        ],
        "package_ndc": [
          "13709-317-01",
          "13709-317-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0705928150034"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}