{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Dr. Sheffield Diaper Rash Zinc Oxide ZINC OXIDE ZINC OXIDE BUTYLATED HYDROXYANISOLE COD LIVER OIL LANOLIN PETROLATUM TALC WATER"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient Zinc Oxide 40%"
      ],
      "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"
      ],
      "warnings": [
        "Warnings For external use only When using this product avoid contact with eyes 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. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product avoid contact with eyes"
      ],
      "stop_use": [
        "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. 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 ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged"
      ],
      "other_safety_information": [
        "Other information store at room temperature 15° - 30°C (59° - 86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients BHA, Cod liver oil, Fragrance, Lanolin, Petrolatum, Talc, Water"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel - Carton Label NDC 11527-058-41 Dr. Sheffield's Made in the USA Diaper Rash Ointment 40% Zinc Oxide Skin Protectant • Promotes healing • Relieves chafing • Paraben free Helps Treat and Prevent Diaper Rash NET WT. 2 oz. (56g) Principal Display Panel - Carton Label",
        "Principal Display Panel - Tube Label NDC 11527-058-41 Dr. Sheffield's Made in the USA Diaper Rash Ointment NET WT. 2 oz. (56g) 40% Zinc Oxide Skin Protectant Helps Treat and Prevent Diaper Rash Principal Display Panel - Tube Label"
      ],
      "set_id": "cac77320-b5cf-4edf-9693-ebabfb61390c",
      "id": "569610c1-6c56-4437-a651-2004d621d8ac",
      "effective_time": "20231128",
      "version": "4",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Dr. Sheffield Diaper Rash"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Sheffield Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "11527-058"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "244638"
        ],
        "spl_id": [
          "569610c1-6c56-4437-a651-2004d621d8ac"
        ],
        "spl_set_id": [
          "cac77320-b5cf-4edf-9693-ebabfb61390c"
        ],
        "package_ndc": [
          "11527-058-41",
          "11527-058-40"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}