{
  "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": [
        "PREOP HYDROGEN PEROXIDE HYDROGEN PEROXIDE HYDROGEN PEROXIDE ETIDRONIC ACID GLYCERIN MENTHA ARVENSIS FLOWER OIL POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM BENZOATE SODIUM CITRATE SODIUM LAURETH SULFATE SUCRALOSE WATER PREOP Pre-Treatment Antiseptic Rinse HYDROGEN PEROXIDE HYDROGEN PEROXIDE ETIDRONIC ACID GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED SODIUM BENZOATE SODIUM CITRATE SODIUM LAURETH SULFATE SUCRALOSE WATER"
      ],
      "spl_unclassified_section": [
        "DRUG FACTS"
      ],
      "active_ingredient": [
        "​Active ingredient Hydrogen Peroxide 2.65%​​"
      ],
      "purpose": [
        "Purpose antiseptic oral rinse"
      ],
      "indications_and_usage": [
        "Uses for dental procedural rinsing to help prevent infection in minor oral irritations"
      ],
      "warnings": [
        "Warnings Do not use this product for more than 7 days unless directed by a dentist or physician."
      ],
      "when_using": [
        "When using this product , do not swallow"
      ],
      "stop_use": [
        "Stop use and ask a doctor if sore mouth symptoms do not improve within 7 days irritations, 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 and older: rinse two pumps (4-5 mL) around in the mouth over the affected area for at least 15 seconds, then spit out • Children under 12 years of age should be supervised in the use of this product • Children under 2 years of age: consult a dentist or physician"
      ],
      "other_safety_information": [
        "Other Information store at controlled room temperature 68-77°F (20 - 25°C)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Etidronic acid, glycerine, menthe arvensis oil, PEG, PVP, sodium benzoate, sodium citrate, sodium lauryl sulfate, sucralose, water"
      ],
      "questions": [
        "Questions? +1 (855) 595-2999"
      ],
      "package_label_principal_display_panel": [
        "EverSmile PREOP​™ PRE-TREATMENT ANTISEPTIC RINSE HYDROGEN PEROXIDE EXPANDING FOAM 16 FL OZ (475 mL) Manufactured by EverBrands, Inc 401 N. Oak St., Inglewood, CA 90302 eversmilewhite.com/preop +1 (855) 595-2999 Mint Bubble Gum res PreOp_Mint_16oz PreOp-BGum 16oz"
      ],
      "set_id": "cc5cdd29-92c1-4ce0-997e-eb624b288b09",
      "id": "4e761e31-1626-4e2a-9697-5160465b6858",
      "effective_time": "20260420",
      "version": "2",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "PREOP"
        ],
        "generic_name": [
          "HYDROGEN PEROXIDE"
        ],
        "manufacturer_name": [
          "Everbrands, Inc."
        ],
        "product_ndc": [
          "72655-200",
          "72655-201"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "HYDROGEN PEROXIDE"
        ],
        "rxcui": [
          "2530801",
          "2530808"
        ],
        "spl_id": [
          "4e761e31-1626-4e2a-9697-5160465b6858"
        ],
        "spl_set_id": [
          "cc5cdd29-92c1-4ce0-997e-eb624b288b09"
        ],
        "package_ndc": [
          "72655-200-01",
          "72655-201-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "BBX060AN9V"
        ]
      }
    }
  ]
}