{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
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  "results": [
    {
      "spl_product_data_elements": [
        "CloSYS Hydrogen Peroxide Hydrogen Peroxide Hydrogen Peroxide Water Propylene Glycol Polysorbate 20 Polysorbate 80 Sucralose Edetate Disodium Menthol, Unspecified Form Citric Acid Monohydrate Front Label Back Label"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        ""
      ],
      "active_ingredient": [
        "Active ingredient Hydrogen Peroxide 1.5% (w/v)"
      ],
      "purpose": [
        "Purpose Oral debriding agent Oral wound cleanser"
      ],
      "indications_and_usage": [
        "Uses For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. Assist in the removal of foreign material from minor oral wounds."
      ],
      "warnings": [
        "Warnings"
      ],
      "keep_out_of_reach_of_children": [
        "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."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 12 years of age and older Use 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician Children 6 years to under 12 years of age: supervise use Children under 6 years of age: do not use"
      ],
      "other_safety_information": [
        "Other Information Do not use if safety seal is broken or missing Cap tightly Keep away from direct sunlight Store at room temperature, 68 to 77°F (20 to 25°C)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients water, polypropylene glycol, flavors, polysorbate 20, polysorbate 80, sucralose, disodium EDTA, menthol, citric acid"
      ],
      "questions": [
        "Questions or comments? call 1-800-643-3337",
        ""
      ],
      "package_label_principal_display_panel": [
        "Packaging A CLEANER MOUTH A HEALTHIER YOU ® CLoSYS ® Oral Debriding Agent MOUTH SORES SENSITIVE MOUTH RINSE PROMOTES HEALING HELPS CLEANSE & PROMOTE HEALING OF ORAL SORES, MOUTH BURNS & IRRITATION For Canker Sores, Cheek Bites, Irritation from Dentures or Braces, Gum Irritation Non Burning, Alcohol-Free Formula Gentle Mint 16 fl oz (473mL) 52516-75 Distributed by: Rowpar Pharmaceuticals, Inc., Bridgewater, NJ 08807 1 (800) 643-3337 closys.com 52516-76"
      ],
      "set_id": "299fc7b1-af6d-4bf9-810f-d35283423fe2",
      "id": "2db642d7-8842-4aac-9deb-6cdbd4d9f955",
      "effective_time": "20251217",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "CloSYS"
        ],
        "generic_name": [
          "HYDROGEN PEROXIDE"
        ],
        "manufacturer_name": [
          "Rowpar Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "58578-0613"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROGEN PEROXIDE"
        ],
        "rxcui": [
          "358975"
        ],
        "spl_id": [
          "2db642d7-8842-4aac-9deb-6cdbd4d9f955"
        ],
        "spl_set_id": [
          "299fc7b1-af6d-4bf9-810f-d35283423fe2"
        ],
        "package_ndc": [
          "58578-0613-1",
          "58578-0613-5",
          "58578-0613-7"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0647692000125"
        ],
        "unii": [
          "BBX060AN9V"
        ]
      }
    }
  ]
}