{
  "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,
      "total": 5
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Zylotrol Lidocaine HCl 4%, Menthol 1% ALOE VERA LEAF WATER ARNICA MONTANA FLOWER INDIAN FRANKINCENSE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ETHYLHEXYLGLYCERIN ISOPROPYL ALCOHOL PHENOXYETHANOL TROLAMINE LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM"
      ],
      "active_ingredient": [
        "Active Ingredients Lidocaine HCl 4% Menthol 1%"
      ],
      "purpose": [
        "Purpose Topical Analgesic"
      ],
      "indications_and_usage": [
        "Uses For the temporary relief of pain."
      ],
      "warnings": [
        "Warnings For external use only not intended for ingestion."
      ],
      "do_not_use": [
        "Do not use in large quantities, particularly over raw surfaces, or blistered areas."
      ],
      "when_using": [
        "When using this product Avoid contact with the eyes."
      ],
      "ask_doctor": [
        "Stop use and ask a doctor if condition worsens, or if symtoms 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 Central right away."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times a daily. Children under 2 years of age: consult a doctor."
      ],
      "other_safety_information": [
        "Other information Store at 20-25 o C (68-77 o F) and protect from moisture."
      ],
      "inactive_ingredient": [
        "Inactive ingredients Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Phenoxyethanol, Triethanolamine."
      ],
      "questions": [
        "Questions? (310) 320-0100"
      ],
      "package_label_principal_display_panel": [
        "box"
      ],
      "set_id": "0e32e9c0-ff5b-4e88-89b1-f5903cd98209",
      "id": "07cf1076-0948-5b74-e063-6294a90a2396",
      "effective_time": "20231016",
      "version": "3",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Zylotrol"
        ],
        "generic_name": [
          "LIDOCAINE HCL 4%, MENTHOL 1%"
        ],
        "manufacturer_name": [
          "Whitestone Products LLC"
        ],
        "product_ndc": [
          "81902-201"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE HYDROCHLORIDE",
          "MENTHOL, UNSPECIFIED FORM"
        ],
        "rxcui": [
          "1373137"
        ],
        "spl_id": [
          "07cf1076-0948-5b74-e063-6294a90a2396"
        ],
        "spl_set_id": [
          "0e32e9c0-ff5b-4e88-89b1-f5903cd98209"
        ],
        "package_ndc": [
          "81902-201-04"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "V13007Z41A",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}