{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Sunmark Benzoin Compound Tincture Benzoin Resin ALCOHOL ALOE TOLU BALSAM BENZOIN RESIN BENZOIN RESIN"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active Ingredient Benzoin"
      ],
      "purpose": [
        "Purpose Protectant"
      ],
      "indications_and_usage": [
        "Use Forms a coating over wound for protecting recurring canker sores"
      ],
      "warnings": [
        "Warnings For external use only. Do not swallow. Do not exceed recommended dosage."
      ],
      "when_using": [
        "When using this product Children under 12 years of age should be supervised in the use of this product. Do not use for more than 7 days unless directed by a dentist or doctor."
      ],
      "stop_use": [
        "Stop use and consult a dentist or 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": [
        "Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more often than every 2 hours. Children under 6 months of age: Consult a dentiest or doctor."
      ],
      "other_safety_information": [
        "Other information Flammable: Keep away from spark, heat or flame."
      ],
      "inactive_ingredient": [
        "Inactive Ingredients Alcohol 77%, Aloe, Storax, Tolu Balsam"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel - 2 oz SMBenz.jpg Sunmark Benzoin Tincture.jpg"
      ],
      "set_id": "0c96d810-83dc-47d3-9a75-63a79feaad0a",
      "id": "0ce57521-f389-2c51-e063-6394a90a3b10",
      "effective_time": "20231219",
      "version": "7",
      "openfda": {
        "application_number": [
          "M022"
        ],
        "brand_name": [
          "Sunmark Benzoin Compound Tincture"
        ],
        "generic_name": [
          "BENZOIN RESIN"
        ],
        "manufacturer_name": [
          "Strategic Sourcing Services LLC"
        ],
        "product_ndc": [
          "49348-138"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "BENZOIN RESIN"
        ],
        "spl_id": [
          "0ce57521-f389-2c51-e063-6394a90a3b10"
        ],
        "spl_set_id": [
          "0c96d810-83dc-47d3-9a75-63a79feaad0a"
        ],
        "package_ndc": [
          "49348-138-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0010939144331"
        ],
        "unii": [
          "GK21SBA74R"
        ]
      }
    }
  ]
}