{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Campho-Phenique Cold Sore Treatment CAMPHOR (SYNTHETIC) and PHENOL SILICON DIOXIDE EUCALYPTUS OIL GLYCERIN LIGHT MINERAL OIL ALOE VERA LEAF CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) PHENOL PHENOL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: Foundation Consumer Healthcare, LLC. Pittsburgh, PA 15205"
      ],
      "active_ingredient": [
        "Active ingredient Camphorated phenol (camphor 10.8% and phenol 4.7%)"
      ],
      "purpose": [
        "Purposes Pain reliever/antiseptic"
      ],
      "indications_and_usage": [
        "Uses for temporary relief of pain and itching associated with cold sores and fever blisters first aid to help prevent infection"
      ],
      "warnings": [
        "Warnings For external use only Do not use over large areas of the body with a bandage Ask a doctor before use if you have a deep or puncture wound animal bites serious burns When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention. Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not induce vomiting before contacting medical help or a Poison Control Center."
      ],
      "do_not_use": [
        "Do not use over large areas of the body with a bandage"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have a deep or puncture wound animal bites serious burns"
      ],
      "when_using": [
        "When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention."
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days"
      ],
      "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. Do not induce vomiting before contacting medical help or a Poison Control Center."
      ],
      "dosage_and_administration": [
        "Directions adults and children 2 years of age and over: clean the affected area apply a small amount of this product to the cold sore or fever blister 1 to 3 times daily do not bandage children under 2 years of age: ask a doctor"
      ],
      "storage_and_handling": [
        "Other information store at room temperature. Avoid excessive heat above 40°C (104°F). close cap tightly after use"
      ],
      "inactive_ingredient": [
        "Inactive ingredients light mineral oil, colloidal silicon dioxide, aloe barbadensis leaf extract, glycerin, eucalyptus oil"
      ],
      "questions": [
        "Questions or comments? 1-855-602-2676 weekdays 9 AM to 5 PM EST"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton with aloe MAXIMUM STRENGTH MEDICATED CAMPHO PHENIQUE ® COLD SORE TREATMENT GEL Fights cold sores with a powerful formula to: immediately relieve pain & itch dry cold sore moisturize surrounding area Helps prevent infection NET WT 0.23 OZ (6.5 g) PRINCIPAL DISPLAY PANEL - 6.5 g Tube Carton"
      ],
      "set_id": "106c0bb2-f2e2-4255-867d-d09ff6a5a2e6",
      "id": "284cb346-f76b-53af-e063-6394a90a2aa4",
      "effective_time": "20241202",
      "version": "4",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Campho-Phenique Cold Sore Treatment"
        ],
        "generic_name": [
          "CAMPHOR (SYNTHETIC) AND PHENOL"
        ],
        "manufacturer_name": [
          "Foundation Consumer Healthcare LLC"
        ],
        "product_ndc": [
          "69536-108"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CAMPHOR (SYNTHETIC)",
          "PHENOL"
        ],
        "rxcui": [
          "210347",
          "308939"
        ],
        "spl_id": [
          "284cb346-f76b-53af-e063-6394a90a2aa4"
        ],
        "spl_set_id": [
          "106c0bb2-f2e2-4255-867d-d09ff6a5a2e6"
        ],
        "package_ndc": [
          "69536-108-23"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "5TJD82A1ET",
          "339NCG44TV"
        ]
      }
    }
  ]
}