{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Blistex Lip Medex PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), and PHENOL PETROLATUM PETROLATUM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) PHENOL PHENOL LANOLIN MICROCRYSTALLINE WAX COCOA BUTTER YELLOW WAX CASTOR OIL MYRISTYL MYRISTATE DIISOPROPYL ADIPATE MENTHYL LACTATE, (-)- BENZYL ALCOHOL 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL MENTHYL SALICYLATE, (+/-)- SACCHARIN EUCALYPTUS OIL CLOVE OIL"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Camphor 1.0% (w/w) External analgesic Menthol 1.0% (w/w) External analgesic Petrolatum 59.14% (w/w) Lip protectant Phenol 0.54% (w/w) External analgesic"
      ],
      "active_ingredient_table": [
        "<table width=\"65%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Camphor 1.0% (w/w)</td><td>External analgesic</td></tr><tr><td>Menthol 1.0% (w/w)</td><td>External analgesic</td></tr><tr><td>Petrolatum 59.14% (w/w)</td><td>Lip protectant</td></tr><tr><td>Phenol 0.54% (w/w)</td><td>External analgesic</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients Purpose Camphor 1.0% (w/w) External analgesic Menthol 1.0% (w/w) External analgesic Petrolatum 59.14% (w/w) Lip protectant Phenol 0.54% (w/w) External analgesic"
      ],
      "purpose_table": [
        "<table width=\"65%\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Camphor 1.0% (w/w)</td><td>External analgesic</td></tr><tr><td>Menthol 1.0% (w/w)</td><td>External analgesic</td></tr><tr><td>Petrolatum 59.14% (w/w)</td><td>Lip protectant</td></tr><tr><td>Phenol 0.54% (w/w)</td><td>External analgesic</td></tr></tbody></table>"
      ],
      "indications_and_usage": [
        "Uses for the temporary relief of pain and itching associated with minor lip irritation temporarily protects and helps relieve chapped or cracked lips helps protect lips from the drying effects of wind and cold weather"
      ],
      "warnings": [
        "Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes do not apply over large areas of the body or bandage Stop use and ask a doctor if condition worsens symptoms last 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_use": [
        "Do not use on deep or puncture wounds animal bites serious burns"
      ],
      "when_using": [
        "When using this product do not get into eyes do not apply over large areas of the body or bandage"
      ],
      "stop_use": [
        "Stop use and ask a doctor if condition worsens symptoms last 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."
      ],
      "dosage_and_administration": [
        "Directions adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily children under 2 years of age: Consult a doctor"
      ],
      "inactive_ingredient": [
        "Inactive ingredients beeswax, benzyl alcohol, diisopropyl adipate, flavors, fragrances, lanolin, menthoxypropanediol, microcrystalline wax, myristyl myristate, ricinus communis (castor) seed oil, saccharin, theobroma cacao (cocoa) seed butter"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack NDC 10157-8407-1 Blistex ® LIP PROTECTANT/ EXTERNAL ANALGESIC LIP MEDEX ® Relieves Sore Lips & Restores Moisture Balance Quickly Cools & Comforts NET WT. .25 oz (7.08g) PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack"
      ],
      "set_id": "8ad39005-9419-4f1a-a1ae-2f76d212455e",
      "id": "c9b9b923-9098-499f-bfa3-509400bb9f82",
      "effective_time": "20240126",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Blistex Lip Medex"
        ],
        "generic_name": [
          "PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOL"
        ],
        "manufacturer_name": [
          "Blistex Inc."
        ],
        "product_ndc": [
          "10157-8407"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "PETROLATUM",
          "MENTHOL, UNSPECIFIED FORM",
          "CAMPHOR (SYNTHETIC)",
          "PHENOL"
        ],
        "spl_id": [
          "c9b9b923-9098-499f-bfa3-509400bb9f82"
        ],
        "spl_set_id": [
          "8ad39005-9419-4f1a-a1ae-2f76d212455e"
        ],
        "package_ndc": [
          "10157-8407-1",
          "10157-8407-2",
          "10157-8407-3",
          "10157-8407-4",
          "10157-8407-5"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041388001715"
        ],
        "unii": [
          "4T6H12BN9U",
          "L7T10EIP3A",
          "5TJD82A1ET",
          "339NCG44TV"
        ]
      }
    }
  ]
}