{
  "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": [
        "Blistex Maximum Hydration Lip camphor (synthetic), dimethicone, unspecified, menthol, unspecified form, and phenol CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) DIMETHICONE, UNSPECIFIED DIMETHICONE, UNSPECIFIED MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM PHENOL PHENOL WATER MINERAL OIL YELLOW WAX PETROLATUM LANOLIN POLYGLYCERYL-3 DIISOSTEARATE PARAFFIN ALCOHOL GLYCERIN ALLANTOIN PEPPERMINT OIL HYDRATED SILICA AMMONIA PALMITIC ACID CETYL ALCOHOL STEARYL ALCOHOL CALCIUM HYDROXIDE LAURIC ACID MYRISTIC ACID SODIUM HYDROXIDE OLEIC ACID EDETATE CALCIUM DISODIUM ANHYDROUS POTASSIUM HYDROXIDE SACCHARIN SODIUM"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredients Purpose Camphor 0.5% (w/w) External analgesic Dimethicone 1.1% (w/w) Lip protectant Menthol 0.625% (w/w) External analgesic Phenol 0.5% (w/w) External analgesic"
      ],
      "active_ingredient_table": [
        "<table width=\"60%\"><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 0.5% (w/w)</td><td>External analgesic</td></tr><tr><td>Dimethicone 1.1% (w/w)</td><td>Lip protectant</td></tr><tr><td>Menthol 0.625% (w/w)</td><td>External analgesic</td></tr><tr><td>Phenol 0.5% (w/w)</td><td>External analgesic</td></tr></tbody></table>"
      ],
      "purpose": [
        "Active ingredients Purpose Camphor 0.5% (w/w) External analgesic Dimethicone 1.1% (w/w) Lip protectant Menthol 0.625% (w/w) External analgesic Phenol 0.5% (w/w) External analgesic"
      ],
      "purpose_table": [
        "<table width=\"60%\"><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 0.5% (w/w)</td><td>External analgesic</td></tr><tr><td>Dimethicone 1.1% (w/w)</td><td>Lip protectant</td></tr><tr><td>Menthol 0.625% (w/w)</td><td>External analgesic</td></tr><tr><td>Phenol 0.5% (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 or cold sores temporarily protects and helps relieve chapped or cracked lips"
      ],
      "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 allantoin, ammonium hydroxide, beeswax, calcium disodium EDTA, calcium hydroxide, cetyl alcohol, flavors, glycerin, hydrated silica, lanolin, lauric acid, mineral oil, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, polyglyceryl-3 diisostearate, potassium hydroxide, purified water, SD alcohol 36, sodium hydroxide, sodium saccharin, stearyl alcohol"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 7 g Tube Carton NEW LARGER SIZE Blistex ® DERMATOLOGIST RECOMMENDED MAXIMUM HYDRATION LIP OINTMENT LIP PROTECTANT/EXTERNAL ANALGESIC + 24HR MOISTURE Medicated Formula Provides Maximum Moisture for Severe Lip Dryness Net Wt. 0.25 oz. (7 g) Ea. Principal Display Panel - 7 g Tube Carton"
      ],
      "set_id": "fed223bc-edf3-46eb-b678-acb906f9ef11",
      "id": "a52e5b7f-f4fd-44ac-80bf-e07140ce49e5",
      "effective_time": "20260518",
      "version": "1",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Blistex Maximum Hydration Lip"
        ],
        "generic_name": [
          "CAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOL"
        ],
        "manufacturer_name": [
          "Blistex Inc."
        ],
        "product_ndc": [
          "10157-9913"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CAMPHOR (SYNTHETIC)",
          "DIMETHICONE, UNSPECIFIED",
          "MENTHOL, UNSPECIFIED FORM",
          "PHENOL"
        ],
        "rxcui": [
          "2107300"
        ],
        "spl_id": [
          "a52e5b7f-f4fd-44ac-80bf-e07140ce49e5"
        ],
        "spl_set_id": [
          "fed223bc-edf3-46eb-b678-acb906f9ef11"
        ],
        "package_ndc": [
          "10157-9913-1",
          "10157-9913-2",
          "10157-9913-3",
          "10157-9913-4"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041388014012"
        ],
        "unii": [
          "5TJD82A1ET",
          "92RU3N3Y1O",
          "L7T10EIP3A",
          "339NCG44TV"
        ]
      }
    }
  ]
}