{
  "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": [
        "DR SMITHS DIAPER Zinc Oxide YELLOW WAX LANOLIN MINERAL OIL OLIVE OIL PARAFFIN PETROLATUM WATER THYMOL IODIDE ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active Ingredient Zinc Oxide 10%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "when_using": [
        "When using this product, avoid contact with the eyes."
      ],
      "stop_use": [
        "See a doctor if condition lasts more than 7 days."
      ],
      "keep_out_of_reach_of_children": [
        "Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions change wet and soiled diapers promptly cleanse the diaper area allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged."
      ],
      "storage_and_handling": [
        "Storage and Handling Store between 15 0 and 30 0 C (59 0 and 86 0 F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Beeswax, lanolin, mineral oil, olive oil, paraffin wax, petrolatum, purified water, thymol iodide"
      ],
      "other_safety_information": [
        "To report a serious adverse event of obtain product information, call (201)-696-8400"
      ],
      "package_label_principal_display_panel": [
        "Carton"
      ],
      "set_id": "7705b182-acf7-4195-9996-7d9fcdfbf055",
      "id": "47e710bf-d93c-068a-e063-6294a90a584b",
      "effective_time": "20260108",
      "version": "10",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "DR SMITHS DIAPER"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Mission Pharmacal"
        ],
        "product_ndc": [
          "0178-0330"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "199099",
          "1494206"
        ],
        "spl_id": [
          "47e710bf-d93c-068a-e063-6294a90a584b"
        ],
        "spl_set_id": [
          "7705b182-acf7-4195-9996-7d9fcdfbf055"
        ],
        "package_ndc": [
          "0178-0330-03",
          "0178-0330-02",
          "0178-0330-08"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}