{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Povidone Iodine Povidone Iodine Gargle 0.5% MENTHOL SACCHARIN SODIUM ANHYDROUS CITRIC ACID GLYCERIN SODIUM HYDROXIDE WATER PROPYLENE GLYCOL PEPPERMINT POVIDONE-IODINE IODINE"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Povidone-Iodine 0.5% (0.05% available iodine)"
      ],
      "purpose": [
        "Purpose Antiseptic"
      ],
      "indications_and_usage": [
        "Use For the temporary relief of occasional sore throat."
      ],
      "warnings": [
        "Warnings Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and voniting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor."
      ],
      "stop_use": [
        "Stop use and consult a doctor if Symptoms do not improve in 7 days. Irritation, pain or redness persists or worsens. Swelling, rash or fever develops."
      ],
      "when_using": [
        "When using this product do not Get into eyes. If contact occurs, rinse eyes thoroughly with water. If iritation persists, consult a doctor. Swallow. Use with hydrogen peroxide."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case more than used for gargling is swallowed, get medical help or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions DO NOT SWALLOW Adults and children 12 years and older: Gargle with 10mL full strength for 30 seconds, then spit out. Use only with dosing cup provided. Use up to 4 times daily. Children under 12: Do not use."
      ],
      "other_safety_information": [
        "Other information Store at 25°C (77°F); Excursions permitted between 15°C and 30°C (59°F-86°F). May stain clothing or dental work. Avoid contact with jewelry, especially silver."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Citric acid, flavor, glycerin, propylene glycol, purified water, saccarin sodium, sodium hydroxide."
      ],
      "do_not_use": [
        "Do not use this product For more than 7 days unless directed by a dentist or doctor. If you are allergic to povidone-iodine or any other ingredients in this product. If you have any thyroid conditions."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding Ask a health professional before use."
      ],
      "package_label_principal_display_panel": [
        "Purdue Gargle Label Gargle Label 2022 Gargle IFC 2022 Gargle Label.jpg Gargle.jpg"
      ],
      "set_id": "a7b9ad55-cfeb-6066-e053-2a95a90af975",
      "id": "0c9380d5-c284-0902-e063-6394a90ac157",
      "effective_time": "20231215",
      "version": "5",
      "openfda": {
        "application_number": [
          "M003"
        ],
        "brand_name": [
          "Povidone Iodine"
        ],
        "generic_name": [
          "POVIDONE IODINE GARGLE 0.5%"
        ],
        "manufacturer_name": [
          "Humco Holding Group, Inc."
        ],
        "product_ndc": [
          "0395-9128"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "POVIDONE-IODINE"
        ],
        "rxcui": [
          "314935"
        ],
        "spl_id": [
          "0c9380d5-c284-0902-e063-6394a90ac157"
        ],
        "spl_set_id": [
          "a7b9ad55-cfeb-6066-e053-2a95a90af975"
        ],
        "package_ndc": [
          "0395-9128-98"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175486",
          "M0011640"
        ],
        "pharm_class_epc": [
          "Antiseptic [EPC]"
        ],
        "pharm_class_cs": [
          "Iodine [CS]"
        ],
        "unii": [
          "85H0HZU99M"
        ]
      }
    }
  ]
}