{
  "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": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Povidone-Iodine Prep POVIDONE-IODINE WATER GLYCERIN POVIDONE-IODINE IODINE"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information • 1% titratable iodine • for hospital or professional use only"
      ],
      "active_ingredient": [
        "Active ingredient Povidone-iodine USP 10% Purpose Antiseptic"
      ],
      "purpose": [
        "Purpose Antiseptic"
      ],
      "indications_and_usage": [
        "Use Antiseptic skin preparation"
      ],
      "warnings": [
        "Warnings For external use only Do not use • if allergic to iodine • in the eyes Ask a doctor before use if injuries are • deep or puncture wounds • serious burns Stop use and ask a doctor if • infection occurs • redness, irritation, swelling or pain persists or increases Avoid pooling beneath patient Avoid excessive heat. Store at room temperature. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately."
      ],
      "do_not_use": [
        "Do not use • if allergic to iodine • in the eyes"
      ],
      "ask_doctor": [
        "Ask a doctor before use if injuries are • deep or puncture wounds • serious burns"
      ],
      "stop_use": [
        "Stop use and ask a doctor if • infection occurs • redness, irritation, swelling or pain persists or increases Avoid pooling beneath patient Avoid excessive heat. Store at room temperature."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately."
      ],
      "dosage_and_administration": [
        "Directions Apply locally as needed"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Purified water, Glycerin, Nonyl nonoxynol-10"
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: Label"
      ],
      "set_id": "f3e0af11-39b6-44a0-8f84-a4b36631e8f0",
      "id": "40b3cd7d-5f77-2f44-e063-6294a90a46e0",
      "effective_time": "20251009",
      "version": "7",
      "openfda": {
        "application_number": [
          "M005"
        ],
        "brand_name": [
          "Povidone-Iodine Prep"
        ],
        "generic_name": [
          "POVIDONE-IODINE"
        ],
        "manufacturer_name": [
          "O&M HALYARD, INC."
        ],
        "product_ndc": [
          "39892-0809"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POVIDONE-IODINE"
        ],
        "rxcui": [
          "312564"
        ],
        "spl_id": [
          "40b3cd7d-5f77-2f44-e063-6294a90a46e0"
        ],
        "spl_set_id": [
          "f3e0af11-39b6-44a0-8f84-a4b36631e8f0"
        ],
        "package_ndc": [
          "39892-0809-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "85H0HZU99M"
        ]
      }
    }
  ]
}