{
  "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": [
        "Leader Zinc Oxide Zinc Oxide ZINC OXIDE ZINC OXIDE MINERAL OIL PETROLATUM"
      ],
      "active_ingredient": [
        "Drug Facts Active Ingredient Zinc oxide 20%"
      ],
      "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. dries the oozing and weeping of poison ivy, poison oak and poison sumac."
      ],
      "warnings": [
        "Warnings For external use only When using this product, avoid contact with the eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days to 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."
      ],
      "when_using": [
        "When using this product, avoid contact with the eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last more than 7 days to 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 apply liberally as often as necessary For Diaper Rash change wet or soiled diapers promptly cleanse the diaper area and allow to dry apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged For Poison Ivy, poison oak and poison sumac; cleanse the affect area and pat dry apply ointment liberally, as often as necessary, using a cotton ball, sterile swab or gauze wash hands after use."
      ],
      "inactive_ingredient": [
        "Inactive ingredients mineral oil, petrolatum"
      ],
      "questions": [
        "Questions or comments? Call 1-800-222-1087 Store at room temperature 20 - 25°C (68° - 77°F)."
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel – Jar Label Leader ® NDC 70000-0334-1 Zinc Oxide Ointment USP• Multi Purpose Skin Protectant provides soothing relief from poison ivy, oak and sumac Treats and prevents diaper rash Net Wt 1 lb (454 g) Principal Display Panel – Jar Label"
      ],
      "set_id": "4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1",
      "id": "4e63f6a0-1c7c-47df-b503-1b9cf3797f9c",
      "effective_time": "20240118",
      "version": "3",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Leader Zinc Oxide"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Cardinal Health 110,Inc."
        ],
        "product_ndc": [
          "70000-0334"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "198911"
        ],
        "spl_id": [
          "4e63f6a0-1c7c-47df-b503-1b9cf3797f9c"
        ],
        "spl_set_id": [
          "4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1"
        ],
        "package_ndc": [
          "70000-0334-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0096295133226"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}