{
  "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
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "ZINC-OXYDE PLUS MENTHOL, ZINC OXIDE BUTYLATED HYDROXYTOLUENE CETYL ESTERS WAX GLYCERIN GLYCERYL MONOSTEARATE LANOLIN POLYOXYL 40 HYDROGENATED CASTOR OIL PHENOL SODIUM BICARBONATE THYMOL PETROLATUM MENTHOL MENTHOL ZINC OXIDE ZINC CATION"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Menthol 0.44% Zinc Oxide 20.6%"
      ],
      "purpose": [
        "Purpose External analgesic / Anti-itch Skin protectant / Anorectal astringent"
      ],
      "indications_and_usage": [
        "Uses A moisture barrier that prevents and helps heal skin irritation from: • urine • diarrhea • perspiration • fistula damage • feeding tube site leakage • wound drainage (peri-wound skin) • minor burns • cuts • scrapes • itching"
      ],
      "warnings": [
        "Warnings For external use only • not for deep or puncture wounds • avoid contact with eyes Stop use and ask a doctor • if condition worsens or does not improve within 7 days. Keep out of reach of children. In case of accidental ingestion contact a physician or poison control center immediately."
      ],
      "stop_use": [
        "Stop use and ask a doctor • if condition worsens or does not improve within 7 days."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of accidental ingestion contact a physician or poison control center immediately."
      ],
      "dosage_and_administration": [
        "Directions cleanse skin gently with mild skin cleanser pat dry or allow to air dry apply a thin layer of ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection."
      ],
      "inactive_ingredient": [
        "Inactive ingredients butylated hydroxytoluene, calamine, cetyl esters, glycerin, glycerol monostearate, lanolin, PEG-40 hydrogenated castor oil, phenol, sodium bicarbonate, thymol, white petrolatum"
      ],
      "questions": [
        "Questions? call 516-783-0274"
      ],
      "package_label_principal_display_panel": [
        "label"
      ],
      "set_id": "cbd899ca-80da-4a1b-9b32-2148759d9424",
      "id": "d8c30b8c-dac8-183a-e053-2a95a90a6a54",
      "effective_time": "20220224",
      "version": "3",
      "openfda": {}
    }
  ]
}