{
  "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,
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    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Gumsol Benzocaine, Zinc Chloride BENZOCAINE BENZOCAINE ZINC CHLORIDE ZINC CATION ASPARTAME CETYLPYRIDINIUM CHLORIDE GLYCERIN MENTHOL, UNSPECIFIED FORM METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Spray Alcohol Free Manufactured in the USA for Kramer Novis, San Juan, PR 00917"
      ],
      "active_ingredient": [
        "Active ingredients (in 30 mL) Benzocaine (5%) Zinc Chloride (0.1%)"
      ],
      "purpose": [
        "Purposes Anesthetic Astringent"
      ],
      "indications_and_usage": [
        "Use Temporarily relieves pain due to toothaches, canker sores or minor mouth injuries of the mouth and gums caused by dentures or orthodontic appliances."
      ],
      "warnings": [
        "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\" anesthetic. If skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly Do not use (unless directed by a doctor): • more than directed • for more than 7 days • in children under 2 years of age • for teething. Stop use and see a doctor promptly if: • sore mouth symptoms do not improve in 7 days • irritation, pain or redness persist or worsen • swelling, rash or fever develops. If pregnant or breast-feeding, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away."
      ],
      "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 12 years of age and older Dry affected area with absorbent cotton. Spray 4 times daily or as directed by physician. Children under 12 years of age Should be supervised in the usage of this product. Children under 2 years of age Do not use."
      ],
      "dosage_and_administration_table": [
        "<table width=\"40%\"><caption/><tbody><tr><td styleCode=\"Botrule Rrule Toprule\">Adults and children 12 years of age and older</td><td styleCode=\"Botrule Toprule\">Dry affected area with absorbent cotton.<paragraph>Spray 4 times daily or as directed by physician.</paragraph></td></tr><tr><td styleCode=\"Botrule Rrule Toprule\">Children under 12 years of age</td><td styleCode=\"Botrule Toprule\">Should be supervised in the usage of this product.</td></tr><tr><td styleCode=\"Botrule Rrule Toprule\">Children under 2 years of age</td><td styleCode=\"Botrule Toprule\"><content styleCode=\"bold\">Do not use.</content></td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information: • Phenylketonurics: Contains phenylalanine 2.5mg/mL. • Store at controlled room temperature: 15°C-30°C (59°F-86°F) • Tamper Evident: Do not use if imprinted foil seal over bottle opening is torn, broken, or missing."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aspartame, cetylpyridinium chloride, glycerin, menthol, methylparaben, peppermint flavor, propylene glycol, propylparaben, and water (purified)."
      ],
      "questions": [
        "Questions or comments? Kramer Novis San Juan, PR 00917. Monday to Friday (8am-4pm). 787-767-2072 www.kramernovis.com"
      ],
      "package_label_principal_display_panel": [
        "Packaging Gumspnew"
      ],
      "set_id": "3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf",
      "id": "df716e50-f0a6-4548-b354-29dd8c29924c",
      "effective_time": "20251115",
      "version": "3",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Gumsol"
        ],
        "generic_name": [
          "BENZOCAINE, ZINC CHLORIDE"
        ],
        "manufacturer_name": [
          "Kramer Novis"
        ],
        "product_ndc": [
          "52083-714"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "BENZOCAINE",
          "ZINC CHLORIDE"
        ],
        "rxcui": [
          "485558"
        ],
        "spl_id": [
          "df716e50-f0a6-4548-b354-29dd8c29924c"
        ],
        "spl_set_id": [
          "3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf"
        ],
        "package_ndc": [
          "52083-714-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000185508",
          "N0000175629",
          "N0000184306",
          "M0000728"
        ],
        "pharm_class_epc": [
          "Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]"
        ],
        "unii": [
          "U3RSY48JW5",
          "86Q357L16B"
        ]
      }
    }
  ]
}