{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "PEROXY SHIELD MOUTH SORE 1.5% Hydrogen Peroxide HYDROGEN PEROXIDE HYDROGEN PEROXIDE METHYL SALICYLATE SUCRALOSE POLOXAMER 407 POLYSORBATE 20 PROPANEDIOL WATER SORBITOL SOLUTION 70% FD&C BLUE NO. 1 SACCHARIN SODIUM MENTHOL"
      ],
      "active_ingredient": [
        "Active ingredient Hydrogen peroxide 1.5% (w/w)"
      ],
      "purpose": [
        "Purpose(s) Oral debriding agent/oral wound cleaner"
      ],
      "indications_and_usage": [
        "Uses 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."
      ],
      "warnings": [
        "Warnings"
      ],
      "do_not_use": [
        "Warnings Do not use this product for more than 7 days unless directed by your dentist or physician."
      ],
      "when_using": [
        "Warnings When using this product, do not swallow."
      ],
      "stop_use": [
        "Warnings Stop use and ask your 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": [
        "Warnings Keep out of reach of children. Children under 12 years of age: consult a dentist of physician. Children under 12 years of age should be supervised in the use of the product. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "Directions For adults and children under 2 years of age or older: rinse 10mL around in 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."
      ],
      "other_safety_information": [
        "Other information Store at controlled room temperature, 20-25°C (68-77°F) and away from direct sunlight. For your protection, do not use if tamper evident seal under the cap is damaged or missing."
      ],
      "inactive_ingredient": [
        "Inactive ingredients FD&C Blue #1, Menthol, Methyl Salicylate, Poloxamer 407, Polysorbate 20, Propylene Glycol, Sodium Saccharin, Sorbitol, Sucralose, Water"
      ],
      "questions": [
        "Questions or comments? Call 1-800-835-0885"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel ALCOHOL FREE PEROXY SHIELD® 1.5% HYDROGEN PEROXIDE MOUTH SORE RINSE HELPS PROMOTE A CLEANER MOUTH & HEALING OF ORAL SORES IRRITATIONS MOUTH BURNS MINT FLAVOR REF. 035-0101-002 63.0 FL. OZ. (1863 mL) Peroxy_image.jpg"
      ],
      "set_id": "a72e433b-1b7d-4a0c-e053-2995a90a30c4",
      "id": "42c86f95-5c63-ba41-e063-6294a90af8c6",
      "effective_time": "20251104",
      "version": "5",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "PEROXY SHIELD MOUTH SORE"
        ],
        "generic_name": [
          "1.5% HYDROGEN PEROXIDE"
        ],
        "manufacturer_name": [
          "Dental Technologies, Inc."
        ],
        "product_ndc": [
          "55346-3501"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROGEN PEROXIDE"
        ],
        "rxcui": [
          "199011",
          "2480895"
        ],
        "spl_id": [
          "42c86f95-5c63-ba41-e063-6294a90af8c6"
        ],
        "spl_set_id": [
          "a72e433b-1b7d-4a0c-e053-2995a90a30c4"
        ],
        "package_ndc": [
          "55346-3501-1",
          "55346-3501-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "BBX060AN9V"
        ]
      }
    }
  ]
}