{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Z-Bum Diaper Rash Cream CETYL ALCOHOL CAPRYLYL GLYCOL LIGHT MINERAL OIL ALOE VERA LEAF GLYCERIN CHLORPHENESIN WATER STEARYL ALCOHOL ALPHA-TOCOPHEROL PETROLATUM PHENOXYETHANOL POLYOXYL 20 CETOSTEARYL ETHER ZINC OXIDE ZINC OXIDE"
      ],
      "spl_unclassified_section": [
        "Z-Bum NDC 58809-375-04 4 oz. (113 grams)"
      ],
      "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 ■ 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 do not get into 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 cream 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 20-30°C (68-86°F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients aloe barbadensis leaf juice, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, petrolatum, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E)"
      ],
      "questions": [
        "Questions or comments? Call 1-888-535-0305 Distributed by: GM Pharmaceuticals, Inc. Arlington, TX 76018"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL NDC 58809-375-04 Z-BUM Zinc Oxide 22% (Skin Protectant) Diaper Rash Cream Premium Protection Helps heal, soothe, and prevent diaper rash Protects chafed skin SOOTHING ALOE & VITAMIN E Gentle on sensitive skin NET WT 4 oz (113 grams) Z-Bum Tube"
      ],
      "set_id": "2a36f396-3a30-3f3f-e054-00144ff8d46c",
      "id": "47e330be-1731-f8ab-e063-6294a90aa44e",
      "effective_time": "20260108",
      "version": "11",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Z-Bum"
        ],
        "generic_name": [
          "DIAPER RASH CREAM"
        ],
        "manufacturer_name": [
          "GM Pharmaceuticals, Inc"
        ],
        "product_ndc": [
          "58809-375"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "1734937",
          "1734942"
        ],
        "spl_id": [
          "47e330be-1731-f8ab-e063-6294a90aa44e"
        ],
        "spl_set_id": [
          "2a36f396-3a30-3f3f-e054-00144ff8d46c"
        ],
        "package_ndc": [
          "58809-375-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}