{
  "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,
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  "results": [
    {
      "spl_product_data_elements": [
        "Periogel HYDROGEN PEROXIDE SACCHARIN SODIUM POLYSORBATE 20 POLOXAMER 407 PHOSPHORIC ACID POTASSIUM SORBATE HYDROGEN PEROXIDE HYDROGEN PEROXIDE SORBITOL XYLITOL MENTHOL METHYL SALICYLATE ALCOHOL WATER"
      ],
      "active_ingredient": [
        "Active Ingredient Hydrogen Peroxide 1.7%(w/w)"
      ],
      "purpose": [
        "Purpose Oral Debriding Agent/Oral Wound Cleanser"
      ],
      "indications_and_usage": [
        "Approved Uses 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."
      ],
      "warnings": [
        "Warnings Do not use for more than 7 days unless directed by a dentist or doctor. Spit out excess medication. 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."
      ],
      "instructions_for_use": [
        "Directions for adults and children 2 years of age and older Apply several drops to the affected area of the mouth. Allow the medication to remain inplace at least 1 minute and then spit out. 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. Children under 2 years of age: Consult a dentist or doctor."
      ],
      "other_safety_information": [
        "Other information Store a controlled room temperature (68-77ºF) in a cool, dry place away from direct sunlight."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Ethyl alcohol (5%w/w), menthol, methyl salicylate, phosphoric acid, poloxamer 407, polysorbate 20, potassium sorbate, sodium saccharin, sorbitol, water, xylitol."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
      ],
      "dosage_and_administration": [
        "Adults and children 2 years of age and older: cut tube tip close to the narrow end. Apply several drops of gel to the affected area of the mouth. Leave in place for at least one minute: spit out. 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 the product. Children under 2 years of age: consult a dentist or doctor."
      ],
      "questions": [
        ""
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Periogel® Oral Debriding Agent/Oral Wound Cleanser (Hydrogen Peroxide) Net Wt. 3oz. (85 g) Tube Box"
      ],
      "set_id": "1f9686b1-eac2-65b7-e063-6394a90a74fb",
      "id": "51c8e21e-5df2-588f-e063-6394a90ae7a4",
      "effective_time": "20260331",
      "version": "5",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Periogel"
        ],
        "generic_name": [
          "HYDROGEN PEROXIDE"
        ],
        "manufacturer_name": [
          "PERIO PROTECT, LLC"
        ],
        "product_ndc": [
          "83381-3204"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "DENTAL"
        ],
        "substance_name": [
          "HYDROGEN PEROXIDE"
        ],
        "rxcui": [
          "1095271",
          "2743349"
        ],
        "spl_id": [
          "51c8e21e-5df2-588f-e063-6394a90ae7a4"
        ],
        "spl_set_id": [
          "1f9686b1-eac2-65b7-e063-6394a90a74fb"
        ],
        "package_ndc": [
          "83381-3204-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0195893739820"
        ],
        "unii": [
          "BBX060AN9V"
        ]
      }
    }
  ]
}