{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Povidone Iodine Gel Swabstick Povidone Iodine Gel Swabstick GLYCERIN HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS WATER POVIDONE-IODINE IODINE"
      ],
      "active_ingredient": [
        "Active Ingredient Povidone-Iodine 10%"
      ],
      "purpose": [
        "Purpose Antiseptic"
      ],
      "indications_and_usage": [
        "Use(s) • For preparation of the skin prior to surgery • First aid to help prevent infection in minor cuts, scrapes, and burns • For venipuncture skin preparation"
      ],
      "warnings": [
        "Warnings For External Use Only"
      ],
      "do_not_use": [
        "Do not use • In the eyes or over large areas of the body • Longer than 1 week unless directed by a doctor"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have • Deep or puncture wounds • Animal bites • Serious burns"
      ],
      "stop_use": [
        "Stop use and ask a doctor if Condition persists or gets worse"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions • Tear at notch • Remove applicator • Use only once As a first aid antiseptic: • Clean affected area • Apply 1 to 3 times daily • May be covered with a sterile bandage • If bandaged, let dry first For preoperative patient skin preparation: • Clean area • Apply to operative site prior to surgery For Venipuncture skin preparation: • Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. Continue this for a minimum of 30 seconds. • After scrubbing for 30 seconds, and using the same applicator, begin at the venipuncture site and move gradually outward in concentric circles to form a total prepped area measuring at least 3 inches in diameter. • Allow site to dry for approximately 30 seconds. • If the patient bend the arm, or if prepared site is touched with the fingers or with any other non-sterile object, the complete preparation must be repeated."
      ],
      "storage_and_handling": [
        "Other Information • Store at room temperature 15º-30ºC (59º-86ºF) • Avoid excessive heat"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Demineralized Water, Disodium Phosphate Anhydrous, Glycerin, Natrozole HHR"
      ],
      "questions": [
        "Questions and Comments? 1-888-369-2739 M-F, 9-5 EST"
      ],
      "package_label_principal_display_panel": [
        "Label NDC 68786-418-01 Label"
      ],
      "set_id": "1058b4ff-c337-7a5a-e063-6394a90aca41",
      "id": "47e7d3e3-b5aa-6b71-e063-6294a90a5633",
      "effective_time": "20260108",
      "version": "2",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "Povidone Iodine Gel Swabstick"
        ],
        "generic_name": [
          "POVIDONE IODINE GEL SWABSTICK"
        ],
        "manufacturer_name": [
          "Sion Biotext Medical Ltd"
        ],
        "product_ndc": [
          "68786-418"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POVIDONE-IODINE"
        ],
        "rxcui": [
          "312562"
        ],
        "spl_id": [
          "47e7d3e3-b5aa-6b71-e063-6294a90a5633"
        ],
        "spl_set_id": [
          "1058b4ff-c337-7a5a-e063-6394a90aca41"
        ],
        "package_ndc": [
          "68786-418-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "85H0HZU99M"
        ]
      }
    }
  ]
}