{
  "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
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Diphenhydramine HCl and Zinc Acetate Extra Strength Itch Relief Continuous Spray DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ZINC ACETATE ZINC CATION GLYCERIN WATER ALOE VERA LEAF ALCOHOL TROMETHAMINE"
      ],
      "active_ingredient": [
        "Active Ingredients Diphenhydramine HCL 2.0% Zinc Acetate 0.1%"
      ],
      "purpose": [
        "Purpose External analgesic Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of pain and itching associated with: minor burns sunburn minor cuts scrapes insect bites minor skin irritations 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. Flammable Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 ºF Intentional misuseby deliberately concentrating and inhaling contents can be harmful or fatal. 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 doctor if condition worsens symptoms last 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."
      ],
      "safe_handling_warning": [
        "Flammable Keep away from fire or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 ºF Intentional misuseby deliberately concentrating and inhaling contents can be harmful or fatal."
      ],
      "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 doctor if condition worsens symptoms last 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 often 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"
      ],
      "other_safety_information": [
        "Other Information store between 20° to 25° C (68° to 77°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients aloe barbadensis leaf juice, glycerin, purified water, SD alcohol 40-B, tromethamine"
      ],
      "questions": [
        "Questions? Call 1-888-423-0139"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel TopCare health EXTRA STRENGTH Itch Relief Continous Spray DIPHENHYDRAMINE HYDROCHLORIDE 2% EXTERNAL ANALGESIC ZINC ACETATE 0.1% SKIN PROTECTANT Relieves Itching from Insect Bites, Poison Ivy, Oak & Sumac Soothes Sunburn & Minor Burns & Cuts NET WT 2.7 OZ (76g) topcare itch relief spray"
      ],
      "set_id": "8026c7dd-eb7b-ebea-e053-2991aa0a1b0f",
      "id": "42f4bfb8-4182-037f-e063-6294a90a9cee",
      "effective_time": "20251106",
      "version": "7",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Diphenhydramine HCl and Zinc Acetate"
        ],
        "generic_name": [
          "EXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAY"
        ],
        "manufacturer_name": [
          "Topco Associates LLC"
        ],
        "product_ndc": [
          "36800-126"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1053138"
        ],
        "spl_id": [
          "42f4bfb8-4182-037f-e063-6294a90a9cee"
        ],
        "spl_set_id": [
          "8026c7dd-eb7b-ebea-e053-2991aa0a1b0f"
        ],
        "package_ndc": [
          "36800-126-76"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40",
          "FM5526K07A"
        ]
      }
    }
  ]
}