{
  "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
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Endit Zinc Oxide Skin Protectant ZINC OXIDE BORIC ACID FERRIC OXIDE RED STARCH, CORN JUNIPER TAR LANOLIN RESORCINOL PETROLATUM ZINC OXIDE ZINC CATION"
      ],
      "active_ingredient": [
        "Active Ingredient: Zinc Oxide 20.00%"
      ],
      "purpose": [
        "Purpose: Skin Protectant"
      ],
      "indications_and_usage": [
        "Uses: Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urine. Protects chafed skin due to diaper rash and helps seal out wetness."
      ],
      "warnings": [
        "Warnings: For external use only. do not get in eyes. When using this product Stop use and ask 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 (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry. Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled dapers (feces, and/or urine) may be prolonged."
      ],
      "inactive_ingredient": [
        "Other Ingredients: Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol, White Petrolatum"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "55b3aa07-871d-421b-b76a-c2d359d6003f",
      "id": "47f5536e-340b-7f85-e063-6394a90ad4a4",
      "effective_time": "20260109",
      "version": "7",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Endit Zinc Oxide Skin Protectant"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Endit Laboratories, Inc."
        ],
        "product_ndc": [
          "64068-402"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "198911"
        ],
        "spl_id": [
          "47f5536e-340b-7f85-e063-6394a90ad4a4"
        ],
        "spl_set_id": [
          "55b3aa07-871d-421b-b76a-c2d359d6003f"
        ],
        "package_ndc": [
          "64068-402-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364068000168"
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}