{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Severe Triple Medicated Gel Benzocaine MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM PETROLATUM MINERAL OIL GELATIN, UNSPECIFIED POLYETHYLENE GLYCOL 1000 FD&C BLUE NO. 1 PECTIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM ZINC CHLORIDE ZINC CATION METHYL SALICYLATE BENZOCAINE BENZOCAINE SACCHARIN SODIUM SACCHARIN Blue to Blue-Green"
      ],
      "active_ingredient": [
        "Benzocaine 20% Menthol 0.5% Zinc Chloride 0.15%"
      ],
      "purpose": [
        "Oral pain reliever Oral pain reliever Astringent"
      ],
      "indications_and_usage": [
        "for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums"
      ],
      "warnings": [
        "Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue or lack of energy Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics Do not use * more that directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergice reaction occurs Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor * children between 2 and 12 years of age should be supervised in the use of this product * children under 2 years of age: do not use"
      ],
      "other_safety_information": [
        "do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted * do not use continuously * this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying"
      ],
      "inactive_ingredient": [
        "blue 1, cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin"
      ],
      "package_label_principal_display_panel": [
        "Carton Artwork"
      ],
      "set_id": "b43ff7a4-dd46-d7d4-e053-2995a90a49f1",
      "id": "b43ff7a4-dd47-d7d4-e053-2995a90a49f1",
      "effective_time": "20201116",
      "version": "1",
      "openfda": {}
    }
  ]
}