{
  "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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    }
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  "results": [
    {
      "spl_product_data_elements": [
        "Medline Zinc oxide DIMETHICONE PETROLATUM CELLULOSE GUM ZINC OXIDE ZINC OXIDE"
      ],
      "active_ingredient": [
        "Active ingredient Zinc oxide 20% w/w"
      ],
      "purpose": [
        "Purpose Skin protectant"
      ],
      "indications_and_usage": [
        "Uses helps treat and prevent diaper rash. Protects minor skin irritation 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 Keep out of reach of children. In case of accidental ingestion, 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. In case of accidental ingestion, 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 product 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 protect from freezing avoid excessive heat"
      ],
      "inactive_ingredient": [
        "Inactive ingredients cellulose gum (CMC), dimethicone, petrolatum"
      ],
      "questions": [
        "Questions? 1-800-MEDLINE (633-5463)"
      ],
      "spl_unclassified_section": [
        "Manufacturing information www.medline.com ©2025 Medline Remedy and Critic-Aid are registered trademarks of Medline Industries, LP. Made in USA of foreign and domestic materials. Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA 1-800-MEDLINE"
      ],
      "package_label_principal_display_panel": [
        "Package Label Package Label-front Package Label-back"
      ],
      "set_id": "3c319953-04fc-87a8-e063-6294a90a5058",
      "id": "509e9818-f9d5-3a4d-e063-6294a90a3e65",
      "effective_time": "20260615",
      "version": "2",
      "openfda": {
        "application_number": [
          "M016"
        ],
        "brand_name": [
          "Medline"
        ],
        "generic_name": [
          "ZINC OXIDE"
        ],
        "manufacturer_name": [
          "Medline Industries, LP"
        ],
        "product_ndc": [
          "53329-255"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "ZINC OXIDE"
        ],
        "rxcui": [
          "416684"
        ],
        "spl_id": [
          "509e9818-f9d5-3a4d-e063-6294a90a3e65"
        ],
        "spl_set_id": [
          "3c319953-04fc-87a8-e063-6294a90a5058"
        ],
        "package_ndc": [
          "53329-255-10",
          "53329-255-05"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "SOI2LOH54Z"
        ]
      }
    }
  ]
}