{
  "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": "2026-07-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Amosan Oral Wound Cleanser Spearmint SODIUM PERBORATE MONOHYDRATE SPEARMINT TARTARIC ACID SACCHARIN SODIUM SODIUM PERBORATE MONOHYDRATE BORATE ION"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Other information do not store above 77°F (25°C)"
      ],
      "active_ingredient": [
        "Active ingredient (in each envelope) Sodium perborate monohydrate 1.2g Purpose Oral Debriding Agent/Oral Wound Cleanser"
      ],
      "purpose": [
        "Purpose Oral Debriding Agent/Oral Wound Cleanser"
      ],
      "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 assist in the removal of foreign material from minor wounds"
      ],
      "warnings": [
        "Warnings For external use only. Do not use for more than 7 days unless directed by a dentist or doctor Stop use and ask a doctor 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. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use for more than 7 days unless directed by a dentist or doctor"
      ],
      "stop_use": [
        "Stop use and ask a doctor 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 swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions adults and children 6 years of age and older: dissolve one envelope in 1 ounce (30 milliliters) of warm water use immediately swish solution around in the mouth over the effected area or gargle for least 1 minute and then spit it out do not swallow use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years of age should be supervised in the use of this product consult a dentist or doctor for use in children under 6 years of age"
      ],
      "inactive_ingredient": [
        "Inactive ingredients L-tartaric acid, sodium saccharin, peppermint flavor"
      ],
      "questions": [
        "Questions or Comments Visit AmosanOralProducts.com or call 1-877-450-6436."
      ],
      "package_label_principal_display_panel": [
        "Package Labeling: 1 inner label"
      ],
      "set_id": "7ac6c649-758f-4128-9920-466c0967b86a",
      "id": "18fc76ba-d1f8-6309-e063-6394a90a5590",
      "effective_time": "20240521",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Amosan Oral Wound Cleanser Spearmint"
        ],
        "generic_name": [
          "SODIUM PERBORATE MONOHYDRATE"
        ],
        "manufacturer_name": [
          "Vintage Brands Limited"
        ],
        "product_ndc": [
          "71223-003"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SODIUM PERBORATE MONOHYDRATE"
        ],
        "spl_id": [
          "18fc76ba-d1f8-6309-e063-6394a90a5590"
        ],
        "spl_set_id": [
          "7ac6c649-758f-4128-9920-466c0967b86a"
        ],
        "package_ndc": [
          "71223-003-00"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "Y9UKD0XE6F"
        ]
      }
    }
  ]
}