{
  "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,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Bite and Itch Diphenhydramine Hydrochloride, Pramoxine Hydrochloride STEARYL ALCOHOL MENTHOL METHYLPARABEN PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER ISOPROPYL MYRISTATE GLYCERYL STEARATE/PEG-100 STEARATE PEG-40 GLYCERYL STEARATE CETYL ALCOHOL DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PROPYLENE GLYCOL DIAZOLIDINYL UREA PROPYLPARABEN White to off-white"
      ],
      "active_ingredient": [
        "Active ingredients Diphenhydramine HCl 2% Pramoxine HCl 1% Purposes Topical analgesic Topical analgesic"
      ],
      "purpose": [
        "Purposes Topical analgesic Topical analgesic"
      ],
      "indications_and_usage": [
        "Uses Temporarily relieves pain and itching due to: scrapes sunburn minor cuts minor burns insect bites minor skin irritations poison ivy, poison oak, or poison sumac"
      ],
      "instructions_for_use": [
        "Directions do not use more often than directed adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor"
      ],
      "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 if you have chicken pox measles When using this product do not get into eyes Stop use and ask a doctor if condition gets worse symptoms last 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 on large areas of the body with any other product containing diphynhydramine, even one taken by mouth Ask a doctor before use if you have chicken pox measles When using this product do not get into eyes Stop use and ask a doctor if conditions get worse symptoms last 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 diphynhydramine, even one taken by mouth"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have chicken pox measles"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if conditions get worse symptoms last 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."
      ],
      "other_safety_information": [
        "Other information store at controlled room temperature call (515) 276-1586 to report any side effects that may occur"
      ],
      "inactive_ingredient": [
        "Inactive ingredients cetyl alcohol, diazolidinyl urea, glyceryl stearate, isopropyl myristate, menthol, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol"
      ],
      "dosage_and_administration": [
        "Directions do not use more often than directed adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor"
      ],
      "recent_major_changes": [
        "Added Dosage and Administration section Updated Warnings section"
      ],
      "package_label_principal_display_panel": [
        "Bite and Itch Lotion Pramoxine HCl 1% Topical Anesthetic Diphenhydramine HCl 2% Antihistamine Pain Relieving Lotion 4 Fl Oz (118 mL) Principal Display Panel"
      ],
      "set_id": "0a4d471b-c3f3-0a6a-e063-6394a90ad57b",
      "id": "28650b5a-ed6f-199c-e063-6394a90a9dac",
      "effective_time": "20241203",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Bite and Itch"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Weeks & Leo Co., Inc."
        ],
        "product_ndc": [
          "11383-192"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "CUTANEOUS"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "PRAMOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1292321"
        ],
        "spl_id": [
          "28650b5a-ed6f-199c-e063-6394a90a9dac"
        ],
        "spl_set_id": [
          "0a4d471b-c3f3-0a6a-e063-6394a90ad57b"
        ],
        "package_ndc": [
          "11383-192-04",
          "11383-192-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40",
          "88AYB867L5"
        ]
      }
    }
  ]
}