{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Blistex Ivarest Poison Ivy Itch Zinc Acetate and PRAMOXINE HYDROCHLORIDE Zinc Acetate ZINC CATION PRAMOXINE HYDROCHLORIDE PRAMOXINE WATER ALCOHOL Propylene Glycol Glycerin POLYOXYL 40 HYDROGENATED CASTOR OIL Phenoxyethanol SODIUM CITRATE, UNSPECIFIED FORM"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Pramoxine HCl 1.0% (w/w) External Analgesic Zinc Acetate 0.12 % (w/w) Skin Protectant"
      ],
      "active_ingredient_table": [
        "<table width=\"55%\"><col width=\"65%\" align=\"left\" valign=\"top\"/><col width=\"35%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Pramoxine HCl 1.0% (w/w)</td><td>External Analgesic</td></tr><tr><td>Zinc Acetate 0.12 % (w/w)</td><td>Skin Protectant</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients Purpose Pramoxine HCl 1.0% (w/w) External Analgesic Zinc Acetate 0.12 % (w/w) Skin Protectant"
      ],
      "purpose_table": [
        "<table width=\"55%\"><col width=\"65%\" align=\"left\" valign=\"top\"/><col width=\"35%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Pramoxine HCl 1.0% (w/w)</td><td>External Analgesic</td></tr><tr><td>Zinc Acetate 0.12 % (w/w)</td><td>Skin Protectant</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of pain and itching associated with poison ivy, poison oak, poison sumac, insect bites or minor skin irritations. dries the oozing and weeping of poison: ivy oak sumac"
      ],
      "warnings": [
        "Warnings For external use only Do not use on large areas of the body When using this product do not get into eyes Stop use and ask a 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."
      ],
      "do_not_use": [
        "Do not use on large areas of the body"
      ],
      "when_using": [
        "When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a 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. as soon as possible after exposure, wash affected area with soap and water. Gently pat dry. apply Ivarest Poison Ivy Itch Spray liberally. wash hands after use. adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily. children under 2 years of age: consult a doctor."
      ],
      "inactive_ingredient": [
        "Inactive ingredients glycerin, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, purified water, SD alcohol 38-B, sodium citrate"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton Quick Relief Spray MAXIMUM STRENGTH IVAREST ® EXTERNAL ANALGESIC/SKIN PROTECTANT POISON IVY ITCH SPRAY Also Great For Insect Bites! No Rub, No Mess Stays Where You Spray It To Protect Affected Area Soothes Skin Fast Relieves Itch and Pain, Comforts Irritated Skin Poison Ivy, Oak & Sumac, Insect Bites, Minor Skin Irritations Net 3.4 fl oz. (100 mL) PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton"
      ],
      "set_id": "e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a",
      "id": "a9095c8d-6e06-4c81-a1a0-4f8b6c957df6",
      "effective_time": "20241211",
      "version": "4",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Blistex Ivarest Poison Ivy Itch"
        ],
        "generic_name": [
          "ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Blistex Inc."
        ],
        "product_ndc": [
          "10157-2100"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC ACETATE",
          "PRAMOXINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1294343"
        ],
        "spl_id": [
          "a9095c8d-6e06-4c81-a1a0-4f8b6c957df6"
        ],
        "spl_set_id": [
          "e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a"
        ],
        "package_ndc": [
          "10157-2100-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "FM5526K07A",
          "88AYB867L5"
        ]
      }
    }
  ]
}