{
  "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": "2026-10-27",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Zinc Oxide 20% Zinc Oxide MINERAL OIL PETROLATUM ZINC OXIDE ZINC OXIDE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Distributed By: Trifecta Pharmaceuticals USA, LLC. 101 NE Third Avenue, Ste. 1500 Ft. Lauderdale, FL. 33301, USA. www.trifecta-pharma.com"
      ],
      "active_ingredient": [
        "Active Ingredient Zinc Oxide 20%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses Protects skin Protects and releives chafed skin due to diaper rash - helps seal out wetness Dries the oozing and weeping of poison ivy, oak and sumac"
      ],
      "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 Apply ointment liberally as often as necessary For the treatment of diaper rash, change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged"
      ],
      "storage_and_handling": [
        "Other Information Store at controlled room temperature 15° - 30°C (59° - 86°F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Mineral Oil, Petrolatum"
      ],
      "package_label_principal_display_panel": [
        "Label 4559 GLOBE ZINC OXIDE OINTMENT 16OZ UPC REV10 122022 CDER"
      ],
      "set_id": "8cbe9b1f-fec0-9579-e053-2995a90ac461",
      "id": "54d824fe-18b9-42a4-e063-6294a90af322",
      "effective_time": "20260622",
      "version": "10",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Zinc Oxide 20%"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Trifecta Pharmaceuticals USA"
        ],
        "product_ndc": [
          "69396-021"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "198911"
        ],
        "spl_id": [
          "54d824fe-18b9-42a4-e063-6294a90af322"
        ],
        "spl_set_id": [
          "8cbe9b1f-fec0-9579-e053-2995a90ac461"
        ],
        "package_ndc": [
          "69396-021-54"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0860001004922"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}