{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Menthol and Zinc Oxide Menthol and Zinc Oxide GLYCERIN FERRIC OXIDE RED LANOLIN LIGHT MINERAL OIL .ALPHA.-TOCOPHEROL ACETATE THYMOL PETROLATUM MENTHOL MENTHOL ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active Ingredients Menthol 0.44% w/w Zinc Oxide 20.625% w/w"
      ],
      "purpose": [
        "Purpose Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant"
      ],
      "indications_and_usage": [
        "uses A moisture barrier that prevents and 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": [
        "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 Keep Out Of Reach Of Children If swallowed , get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Dosage & Administration: Clean skin with mild skin cleanser Pat dry or allow to air dry Apply a thin layer of Calasoothe 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 Calamine, Glycerine, Lanolin, Light Liquid Paraffin, Petrolatum, Thymol, Tocopheryl Acetate"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Principal Display and Drug Fact Panel"
      ],
      "set_id": "e673d8bd-2573-9f04-e053-2995a90a172a",
      "id": "2b0e344b-8e5b-2995-e063-6394a90a9cbc",
      "effective_time": "20250106",
      "version": "3",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Menthol and Zinc Oxide"
        ],
        "generic_name": [
          "MENTHOL AND ZINC OXIDE"
        ],
        "manufacturer_name": [
          "GERI-GENTLE CORPORATION"
        ],
        "product_ndc": [
          "69771-013"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL",
          "ZINC OXIDE"
        ],
        "rxcui": [
          "2123045"
        ],
        "spl_id": [
          "2b0e344b-8e5b-2995-e063-6394a90a9cbc"
        ],
        "spl_set_id": [
          "e673d8bd-2573-9f04-e053-2995a90a172a"
        ],
        "package_ndc": [
          "69771-013-23"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0648289041217"
        ],
        "unii": [
          "L7T10EIP3A",
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}