{
  "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": [
        "OxiStom Oral Wound Cleanser HYDROGEN PEROXIDE HYDROGEN PEROXIDE XYLITOL METHYL SALICYLATE PROPYLENE GLYCOL POLYOXYL 40 HYDROGENATED CASTOR OIL WATER PRO-SYS Oral Wound Cleanser HYDROGEN PEROXIDE HYDROGEN PEROXIDE XYLITOL METHYL SALICYLATE PROPYLENE GLYCOL POLYOXYL 40 HYDROGENATED CASTOR OIL WATER"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Methyl Salicylate, PEG-40, Propylene Glycol, Water, Xylitol"
      ],
      "questions": [
        "Questions? 1-855-696-7254"
      ],
      "active_ingredient": [
        "Active Ingredient Hydrogen Peroxide 1.5% (w/v)"
      ],
      "purpose": [
        "Purpose Oral Debriding Agent / Oral Wound Cleanser"
      ],
      "storage_and_handling": [
        "Other Information Store at controlled room temperatures 68 - 77ºF (20 - 25ºC) and away from direct sunlight. Keep cap tightly closed when not in use."
      ],
      "indications_and_usage": [
        "Uses • Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth. • For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. • For temporary use to cleanse canker sores. • Assists in the removal of foreign material from minor oral wounds."
      ],
      "warnings": [
        "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 dentist or physician if: • sore mouth symptoms do not improve in 7 days; • irritation, pain, or redness persists or worsens; • swelling, rash, or fever develops."
      ],
      "keep_out_of_reach_of_children": [
        "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 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the 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.",
        "Directions • Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the 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."
      ],
      "package_label_principal_display_panel": [
        "image OX 16oz",
        "prosys 16oz"
      ],
      "set_id": "c357c8f8-6fd6-c2f8-e053-2995a90a4023",
      "id": "57dbfe25-5b60-3ad1-e063-6294a90a0a76",
      "effective_time": "20260730",
      "version": "7",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "PRO-SYS",
          "OxiStom"
        ],
        "generic_name": [
          "ORAL WOUND CLEANSER"
        ],
        "manufacturer_name": [
          "Forward Science Technologies LLC"
        ],
        "product_ndc": [
          "70275-201",
          "70275-937"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "HYDROGEN PEROXIDE"
        ],
        "rxcui": [
          "205336"
        ],
        "spl_id": [
          "57dbfe25-5b60-3ad1-e063-6294a90a0a76"
        ],
        "spl_set_id": [
          "c357c8f8-6fd6-c2f8-e053-2995a90a4023"
        ],
        "package_ndc": [
          "70275-937-13",
          "70275-937-16",
          "70275-201-16",
          "70275-201-28"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370275937166"
        ],
        "unii": [
          "BBX060AN9V"
        ]
      }
    }
  ]
}