{
  "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": [
        "ProCure Zinc Oxide Zinc Oxide ZINC OXIDE ZINC OXIDE LIGHT MINERAL OIL WHITE PETROLATUM CETEARETH-20 CETOSTEARYL ALCOHOL"
      ],
      "active_ingredient": [
        "Active Ingredient Zinc Oxide"
      ],
      "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 ozzing and weeping of poison ivy, poison oak and posion sumac"
      ],
      "warnings": [
        "Warnings Warnings For external use only. When using this product When using this product do not get into eyes Stop use and ask a doctor if 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"
      ],
      "when_using": [
        "When using this product When using this product do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if 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": [
        "Directions Directions: For Diaper Rash: change wet and soiled diapers promptly cleanse the siaper area and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diapers may be prolonged For poison ivy, oak and suman: apply as needed"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Inactive ingredients: Ceteareth 20, Cetostearyl Alcohol, Light Mineral Oil, Petrolatum"
      ],
      "package_label_principal_display_panel": [
        "PCZO01 Image"
      ],
      "set_id": "37a30ee5-fd33-b410-e063-6294a90aef72",
      "id": "4ee11cb5-7447-6745-e063-6394a90a5fbf",
      "effective_time": "20260407",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "ProCure Zinc Oxide"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Twin Med LLC"
        ],
        "product_ndc": [
          "55681-017"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "198911"
        ],
        "spl_id": [
          "4ee11cb5-7447-6745-e063-6394a90a5fbf"
        ],
        "spl_set_id": [
          "37a30ee5-fd33-b410-e063-6294a90aef72"
        ],
        "package_ndc": [
          "55681-017-01",
          "55681-017-02",
          "55681-017-15"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}