{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Zinc Oxide 40% Diaper Rash Skin Protectent LANOLIN GLYCERIN YELLOW WAX PETROLATUM COD LIVER OIL PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE SORBITAN SESQUIOLEATE .ALPHA.-TOCOPHEROL ACETATE STARCH, CORN ZINC OXIDE ZINC OXIDE"
      ],
      "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 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 If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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": [
        "If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions change wet and soiled diapers promptly cleanse the diaper area allow to dry apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged wipe tip clean after each use reapply firmly to lock applicator when not in use"
      ],
      "storage_and_handling": [
        "Other Information store at 59°F to 87°F"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients beeswax, cod liver oil, glycerine, lanolin, sorbitan sesquioleate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopheryl acetate, petrolatum"
      ],
      "questions": [
        "Questions and comments? 1-877-469-8877"
      ],
      "package_label_principal_display_panel": [
        "Label be"
      ],
      "set_id": "2992285b-bcdb-c0da-e063-6294a90ac650",
      "id": "3cb8e59e-357b-cb5a-e063-6294a90a9257",
      "effective_time": "20250819",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Zinc Oxide 40%"
        ],
        "generic_name": [
          "DIAPER RASH SKIN PROTECTENT"
        ],
        "manufacturer_name": [
          "ELEEO BRANDS LLC"
        ],
        "product_ndc": [
          "79747-009"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "spl_id": [
          "3cb8e59e-357b-cb5a-e063-6294a90a9257"
        ],
        "spl_set_id": [
          "2992285b-bcdb-c0da-e063-6294a90ac650"
        ],
        "package_ndc": [
          "79747-009-13"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}