{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "Betadine POVIDONE-IODINE POVIDONE-IODINE IODINE C12-15 Pareth-9 Water Sodium Hydroxide Bottle Label"
      ],
      "active_ingredient": [
        "Drug Facts Active ingredients Povidone-iodine, 5% (0.5% available iodine)"
      ],
      "purpose": [
        "Purpose First aid Antiseptic"
      ],
      "indications_and_usage": [
        "Uses First aid to help prevent infection in minor cuts scrapes burns"
      ],
      "warnings": [
        "Warnings For external use only"
      ],
      "do_not_use": [
        "Do not use in the eyes over large areas of the body If you are allergic to povidone-iodine or any other ingredients in this preparation"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have deep or puncture wounds serious burns animal bites"
      ],
      "stop_use": [
        "Stop use and ask a doctor if the condition persists or gets worse you need to use this product for more than 1 week"
      ],
      "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 clean the affected area spray a small amount of the product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first"
      ],
      "storage_and_handling": [
        "Other information store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do Not Freeze"
      ],
      "inactive_ingredient": [
        "Inactive ingredients pareth 25-9, purified water, sodium hydroxide Questions? 1-833-288-2684"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NEW LOOK! HOSPITAL TRUSTED SINCE 1955 BETADINE ® ANTISEPTIC 5% POVIDONE-IODINE First Aid Antiseptic Spray √ Ideal for Minor Cuts, Wounds, Scrapes & Burns √ Kills 99.9% of Germs * To Prevent Infection √ Works in Seconds t √ No Stinging or Burning 3 fl oz (88.7mL) Helps protect against skin infection Golden brown color indicates area treated Visit www.Betadine.com for more information * commonlly associated with skin infections. t based on in vitro lab data. Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 USA ©2024 Atlantis Consumer Healthcare Inc. Betadine is a registered trademark of Atlantis Consumer Healthcare Inc. A0324"
      ],
      "set_id": "00002127-02bc-4c66-b0c3-ca29d8224afc",
      "id": "b8f5797b-73e1-4201-b824-2cdd50c90497",
      "effective_time": "20250102",
      "version": "1",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "Betadine"
        ],
        "generic_name": [
          "POVIDONE-IODINE"
        ],
        "manufacturer_name": [
          "Atlantis Consumer Healthcare, Inc."
        ],
        "product_ndc": [
          "67618-192"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POVIDONE-IODINE"
        ],
        "rxcui": [
          "108204",
          "238850"
        ],
        "spl_id": [
          "b8f5797b-73e1-4201-b824-2cdd50c90497"
        ],
        "spl_set_id": [
          "00002127-02bc-4c66-b0c3-ca29d8224afc"
        ],
        "package_ndc": [
          "67618-192-03"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0367618160039"
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "85H0HZU99M"
        ]
      }
    }
  ]
}