{
  "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": [
        "Extra Strength Itch Stopping Itch Stopping Cream PROPYLPARABEN WATER POTASSIUM HYDROXIDE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ZINC ACETATE ZINC CATION CETYL ALCOHOL DIAZOLIDINYL UREA METHYLPARABEN PROPYLENE GLYCOL"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison ivy, poison oak, and poison sumac"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed by: Universal Distribution Centre LLC 96 Distribution Boulevard, Edison NJ 08817"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant"
      ],
      "active_ingredient_table": [
        "<table width=\"70%\"><col align=\"left\" valign=\"top\" width=\"60%\"/><col align=\"left\" valign=\"top\" width=\"40%\"/><thead><tr><th>Active ingredients</th><th>Purpose</th></tr></thead><tbody><tr><td>Diphenhydramine hydrochloride 2%</td><td>Topical analgesic</td></tr><tr><td>Zinc acetate 0.1%</td><td>Skin protectant</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients Purpose Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant"
      ],
      "purpose_table": [
        "<table width=\"70%\"><col align=\"left\" valign=\"top\" width=\"60%\"/><col align=\"left\" valign=\"top\" width=\"40%\"/><thead><tr><th>Active ingredients</th><th>Purpose</th></tr></thead><tbody><tr><td>Diphenhydramine hydrochloride 2%</td><td>Topical analgesic</td></tr><tr><td>Zinc acetate 0.1%</td><td>Skin protectant</td></tr></tbody></table>"
      ],
      "warnings": [
        "Warnings For external use only Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use on chicken pox on measles When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days 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 on large areas of the body with any other product containing diphenhydramine, even one taken by mouth"
      ],
      "ask_doctor": [
        "Ask a doctor before use on chicken pox on measles"
      ],
      "when_using": [
        "When using this product avoid contact with eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist for more than 7 days or clear up and occur again within a few days"
      ],
      "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 do not use more than directed 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"
      ],
      "storage_and_handling": [
        "Other information protect from excessive heat (40°C/104°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water"
      ],
      "questions": [
        "Questions? Call toll-free 1-800-222-1222"
      ],
      "recent_major_changes": [
        ""
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton EXTRA STRENGTH Topical Analgesic/Skin Protectant ITCH STOPPING CREAM NET WT 1.25 OZ (35.4 g) Label"
      ],
      "set_id": "b9a42aa3-1903-76f0-e053-2a95a90a51d1",
      "id": "1853be3d-62de-dc6b-e063-6394a90aad99",
      "effective_time": "20240513",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Extra Strength Itch Stopping"
        ],
        "generic_name": [
          "ITCH STOPPING CREAM"
        ],
        "manufacturer_name": [
          "Universal Distribution Centre LLC"
        ],
        "product_ndc": [
          "52000-071"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1087026"
        ],
        "spl_id": [
          "1853be3d-62de-dc6b-e063-6394a90aad99"
        ],
        "spl_set_id": [
          "b9a42aa3-1903-76f0-e053-2a95a90a51d1"
        ],
        "package_ndc": [
          "52000-071-03",
          "52000-071-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40",
          "FM5526K07A"
        ]
      }
    }
  ]
}