{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Intensive Healing Itch Relief Itch Relief cream CETEARYL ALCOHOL ISOSTEARYL NEOPENTANOATE CETYL PALMITATE .ALPHA.-TOCOPHEROL ACETATE GLYCERIN METHYLPARABEN WATER ASCORBIC ACID CETEARETH-20 POLYOXYL STEARATE 40 LIQUID PETROLEUM ALOE VERA LEAF ISOPROPYL MYRISTATE VITAMIN D HYDROCORTISONE HYDROCORTISONE RETINYL PALMITATE CHAMOMILE BENZYL ALCOHOL"
      ],
      "active_ingredient": [
        "Drug Facts Active ingredient Hydrocortisone, USP 1% Purpose Anti-itch\\ Drug Facts"
      ],
      "purpose": [
        "Uses eczema psoriasis seborrheic dermatitis poison ivy poison oak poison sumac insect bites soaps detergents cosmetics jewelry for external genital, feminine and anal itching other uses of this product should be only under the advice and supervision of a doctor Uses"
      ],
      "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 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 told to do so by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator 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 Warnings"
      ],
      "ask_doctor": [
        "Ask a doctor if Do Not Use: For external feminine itching if you have a vaginal discharge. Consult a doctor. Do Not Use: For the treatment of diaper rash, consult a doctor. 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. Ask a doctor if"
      ],
      "stop_use": [
        "Stop use and ask a doctor if 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. Stop use and ask a doctor if"
      ],
      "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 told to do so by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator When using this product"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding ask a health professional before use If pregnant or breast-feeding"
      ],
      "keep_out_of_reach_of_children": [
        "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. Keep out of reach of children"
      ],
      "instructions_for_use": [
        "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. 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. Directions"
      ],
      "other_safety_information": [
        "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. Other Information"
      ],
      "inactive_ingredient": [
        "Inactive Ingredient aloe vera leaf, ascorbic acid, benzyl alcohol, ceteareth-20, cetearyl alcohol, cetyl palmitate, chamomile extract, glycerin, isopropyl myristate, isostearyl neopentanoate, methyl paraben, PEG-40 stearate, petroleum, purified water, retinyl palmitate, tocopheryl acetate, vitamin D Inactive Ingredients"
      ],
      "indications_and_usage": [
        "Uses For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis seborrheic dermatitis poison ivy poison oak poison sumac insect bites soaps detergents cosmetics jewelry for external genital, feminine and anal itching other uses of this product should be only under the advice and supervision of a doctor Indications and Uses"
      ],
      "dosage_and_administration": [
        "Dosage and Administration 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. 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. Directions"
      ],
      "do_not_use": [
        "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. Do not use"
      ],
      "package_label_principal_display_panel": [
        "Package Label Intensive Healing Itch Relief Cream Hydrocortisone 1% Maximum Strength 24 Hour Moisture Soothing relief from itching, rashes, redness, inflammation and other skin irritations NET WT 2 OZ (57 g) Package Label"
      ],
      "set_id": "563ef1d5-2180-bc45-e063-6294a90a813d",
      "id": "563ef1d5-2181-bc45-e063-6294a90a813d",
      "effective_time": "20260710",
      "version": "1",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Intensive Healing Itch Relief"
        ],
        "generic_name": [
          "ITCH RELIEF CREAM"
        ],
        "manufacturer_name": [
          "NeilMed Pharmaceuticals Inc"
        ],
        "product_ndc": [
          "13709-359"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "HYDROCORTISONE"
        ],
        "rxcui": [
          "106258"
        ],
        "spl_id": [
          "563ef1d5-2181-bc45-e063-6294a90a813d"
        ],
        "spl_set_id": [
          "563ef1d5-2180-bc45-e063-6294a90a813d"
        ],
        "package_ndc": [
          "13709-359-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ"
        ]
      }
    }
  ]
}