{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "ALBOTHYL Policresulen Solution WATER POLICRESULEN POLICRESULEN"
      ],
      "active_ingredient": [
        "Policresulen Solution"
      ],
      "purpose": [
        "Oral debriding agent/oral wound cleanser for temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums such as mouth burns, cheek bites and toothbrush abrasions. Cleans minor mouth wounds by removing foreign materials that can impede the healing process"
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children"
      ],
      "indications_and_usage": [
        "Adults and children 2 years of age and older: rinse half of a capful around in the mouth over affected area for at least 1 minute, then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician. Children under 12 years of age should be supervised in the use of the product. Children under 2 years of age: consult a dentist or physician. To open child safety cap, squeeze smooth sides while turning. Reclose tightly"
      ],
      "warnings": [
        "Do not use this product for more than 7 days unless directed by a dentist or physician. When using this product, do not swallow. Stop use and ask a doctor if. Sore mouth symptoms do not improve within 7 days. Irritation, pain or redness persists or worsens. Swelling, rash or fever develops. Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if carton is opened. Do not use if printed band on bottle is broken or missing"
      ],
      "inactive_ingredient": [
        "Water; Sorbitol; Propylene Glycol; Poloxamer"
      ],
      "dosage_and_administration": [
        "for oral use"
      ],
      "package_label_principal_display_panel": [
        "label"
      ],
      "set_id": "f2ea4e1b-a3d7-d063-e053-2a95a90a6d0b",
      "id": "001d54ef-148b-e55a-e063-6294a90a7c40",
      "effective_time": "20230710",
      "version": "3",
      "openfda": {
        "brand_name": [
          "ALBOTHYL"
        ],
        "generic_name": [
          "POLICRESULEN SOLUTION"
        ],
        "manufacturer_name": [
          "Lydia Co., Ltd."
        ],
        "product_ndc": [
          "72988-0035"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POLICRESULEN"
        ],
        "spl_id": [
          "001d54ef-148b-e55a-e063-6294a90a7c40"
        ],
        "spl_set_id": [
          "f2ea4e1b-a3d7-d063-e053-2a95a90a6d0b"
        ],
        "package_ndc": [
          "72988-0035-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "6I19M5GB0G"
        ]
      }
    }
  ]
}