{
  "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": "2026-10-29",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Zinc Oxide 20% Zinc Oxide MINERAL OIL ZINC OXIDE ZINC OXIDE PETROLATUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed By: Pharmacy Value Alliance, LLC. 407 East Lancaster Avenue, Wayne, PA. 19087 www.emersongroup.com Product of PRC"
      ],
      "active_ingredient": [
        "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 - helps protect skin from wetness Protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac Helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "warnings": [
        "Warnings For External Use Only When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition."
      ],
      "dosage_and_administration": [
        "Directions Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply ointment liberally as often as necessary. With each diaper change, especially at betime or anytime when exposure to wet diapers may be prolonged"
      ],
      "storage_and_handling": [
        "Other Information Store at controlled room temperature 20° - 25°C (68° - 77°F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Mineral Oil, Petrolatum"
      ],
      "package_label_principal_display_panel": [
        "Packaging Emerson Zinc Oxide"
      ],
      "set_id": "38018e3f-3778-01d1-e054-00144ff8d46c",
      "id": "29b7387b-ad70-3a11-e063-6394a90a6a15",
      "effective_time": "20241220",
      "version": "5",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Zinc Oxide 20%"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Pharmacy Value Alliance, LLC"
        ],
        "product_ndc": [
          "68016-159"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "198911"
        ],
        "spl_id": [
          "29b7387b-ad70-3a11-e063-6394a90a6a15"
        ],
        "spl_set_id": [
          "38018e3f-3778-01d1-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "68016-159-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0840986012778"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}