{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Banophen Diphenhydramine Hydrochloride, Zinc Acetate DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ZINC ACETATE ZINC CATION CETYL ALCOHOL DIAZOLIDINYL UREA METHYLPARABEN DIETHYLENE GLYCOL MONO- AND DIPALMITOSTEARATE PEG-20 STEARATE PROPYLENE GLYCOL PROPYLPARABEN WATER"
      ],
      "active_ingredient": [
        "Active ingredients Diphenhydramine hydrochloride 2% Zinc acetate 0.1%"
      ],
      "purpose": [
        "Purpose Topical analgesic Skin protectant"
      ],
      "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"
      ],
      "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 the 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. (1-800-222-1222)"
      ],
      "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 the 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. (1-800-222-1222)"
      ],
      "dosage_and_administration": [
        "Directions • do not use more than directed • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily • children under 2 years of age: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information • store at 20°-25°C (68°-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients cetyl alcohol, diazolidinyl urea, methylparaben, PEG-2 stearate, PEG-20 stearate, propylene glycol, propylparaben, purified water"
      ],
      "questions": [
        "Questions or comments? 1-800-719-9260"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel MAJOR® compare to the active ingredients in Extra Strength Benadryl® Itch Stopping Cream extra strength banophen™ diphenhydramine HCl 2% zinc acetate 0.1% anti-itch cream topical analgesic skin protectant net wt 1 oz (28 g) major-banophen-carton-image.jpg"
      ],
      "set_id": "9758d886-bd58-4eb2-a827-fa8e7fee2b7c",
      "id": "9d9d4074-238a-49d0-a5ef-39414da07434",
      "effective_time": "20260213",
      "version": "5",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Banophen"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-5354"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1087026",
          "1092428"
        ],
        "spl_id": [
          "9d9d4074-238a-49d0-a5ef-39414da07434"
        ],
        "spl_set_id": [
          "9758d886-bd58-4eb2-a827-fa8e7fee2b7c"
        ],
        "package_ndc": [
          "0904-5354-31"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40",
          "FM5526K07A"
        ]
      }
    }
  ]
}