{
  "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,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Zinc Oxide Zinc Oxide ZINC OXIDE ZINC OXIDE CETYL ALCOHOL MINERAL OIL ALOE VERA LEAF GLYCERIN WATER STEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE PETROLATUM GLYCERYL STEARATE SE ISOPROPYL PALMITATE PEG-100 MONOSTEARATE PHENOXYETHANOL"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide 22%"
      ],
      "purpose": [
        "Purpose Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect skin from wetness."
      ],
      "warnings": [
        "Warnings For external use only When using this product do not get into eyes Stop use and ask a doctor if conditions worsen symptoms last more than 7 days or 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 do not get into eyes"
      ],
      "stop_use": [
        "Stop use and ask a doctor if conditions worsen 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. 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, and allow to dry. apply cream 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": [
        "Other information store at 20-30°C (68-86 °F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients aloe barbadensis leaf juice, cetyl alcohol, glycerin, glyceryl stearate SE, isopropyl palmitate, mineral oil, PEG-100 stearate, phenoxyethanol, purified water, tocopheryl acetate (vitamin E), stearyl alcohol, white petrolatum"
      ],
      "questions": [
        "Questions? Call 1-844-221-7294."
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 113 gram Tube Label Soothing Aloe & Vitamin E NDC 69367-188-04 Zinc Oxide 22% Daily Moisturizing Diaper Rash Cream Premium Skin Protectant Helps Heal, Soothe & Prevent Diaper Rash Protects Chafed Skin Gentle on Sensitive Skin NET WT: 4 oz (113 grams) Westminster Pharmaceuticals PRINCIPAL DISPLAY PANEL - 113 gram Tube Label"
      ],
      "set_id": "7e045b3a-f33b-4faa-ab9b-2baec6ff7924",
      "id": "f9d7570e-1da1-4050-b2f1-72aeeb7359e3",
      "effective_time": "20250708",
      "version": "9",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Zinc Oxide"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Westminster Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "69367-188"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1734937"
        ],
        "spl_id": [
          "f9d7570e-1da1-4050-b2f1-72aeeb7359e3"
        ],
        "spl_set_id": [
          "7e045b3a-f33b-4faa-ab9b-2baec6ff7924"
        ],
        "package_ndc": [
          "69367-188-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}