{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Menthol and Zinc Oxide Menthol and Zinc Oxide GLYCERIN SODIUM BICARBONATE WHITE PETROLATUM LANOLIN THYMOL FERRIC OXIDE RED MINERAL OIL PARAFFIN PHENOL ISOPROPYL ALCOHOL MENTHOL MENTHOL ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active Ingredients Menthol 0.44% Zinc Oxide 20.625%"
      ],
      "purpose": [
        "Purpose External Analgesic Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses A moisture barrier that prevents & helps heal skin irritations from: Urine Diarrhea Perspiration Fistula drainage 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 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."
      ],
      "ask_doctor": [
        "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 Cleans 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."
      ],
      "storage_and_handling": [
        "Other Information Store at room temperature 20°- 25° C (68°F-77°F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol, White Soft Paraffin, Isopropyl Alcohol, Hard Paraffin"
      ],
      "package_label_principal_display_panel": [
        "Package label Menthol and Zinc Oxide Ointment 701-04"
      ],
      "set_id": "c24e2dab-cab4-38f4-e053-2995a90aabae",
      "id": "4527ab64-b939-8e53-e063-6294a90a07a2",
      "effective_time": "20251204",
      "version": "5",
      "openfda": {
        "application_number": [
          "M015"
        ],
        "brand_name": [
          "Menthol and Zinc Oxide"
        ],
        "generic_name": [
          "MENTHOL AND ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Marlex Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "10135-701"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "2123045"
        ],
        "spl_id": [
          "4527ab64-b939-8e53-e063-6294a90a07a2"
        ],
        "spl_set_id": [
          "c24e2dab-cab4-38f4-e053-2995a90aabae"
        ],
        "package_ndc": [
          "10135-701-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L7T10EIP3A",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}