{
  "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,
      "total": 12
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Westlake Itch Relief Diphenhydramine HCl, Zinc Acetate ZINC ACETATE ZINC CATION WATER GLYCERIN ALCOHOL POVIDONE K30 TROLAMINE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE"
      ],
      "active_ingredient": [
        "Active Ingredient Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant"
      ],
      "indications_and_usage": [
        "Uses for temporary relieves pain and itching due to: 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 oak sumac"
      ],
      "dosage_and_administration": [
        "Directions do not use more often than directed adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor"
      ],
      "warnings_and_cautions": [
        "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 doctor Before use on chicken pox on measles When using this product do not get into eyes Stop Use and ask physician 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. Warning for external use only"
      ],
      "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 doctor Before use on chicken pox on measles"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop Use and ask physician 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."
      ],
      "warnings": [
        "Warning for external use only"
      ],
      "purpose": [
        "Purposes Itch relief"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Purified Water, Glycerin, SD Alcohol, Povidone, Povidonee (K-30), Trolamine"
      ],
      "package_label_principal_display_panel": [
        "Prinicpal dispaly panel Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant Relieves Itch and Pain associated with insects bites & rashes due to posinon ivy Oak& sumac Principal Display Panel"
      ],
      "set_id": "0c416ba6-b01f-0609-e063-6294a90ae2a1",
      "id": "0c419012-62b2-e052-e063-6394a90ab7ad",
      "effective_time": "20231211",
      "version": "1",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Westlake Itch Relief"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HCL, ZINC ACETATE"
        ],
        "manufacturer_name": [
          "Westlake HB Pharma LLC"
        ],
        "product_ndc": [
          "82895-715"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "ZINC ACETATE"
        ],
        "rxcui": [
          "1053138"
        ],
        "spl_id": [
          "0c419012-62b2-e052-e063-6394a90ab7ad"
        ],
        "spl_set_id": [
          "0c416ba6-b01f-0609-e063-6294a90ae2a1"
        ],
        "package_ndc": [
          "82895-715-60"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40",
          "FM5526K07A"
        ]
      }
    }
  ]
}