{
  "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": 19
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "DZUL - LIDO CREME LIDOCAINE HCL, MENTHOL ALMOND OIL DIMETHYL SULFONE ISOPROPYL MYRISTATE METHYLPROPANEDIOL ARNICA MONTANA FLOWER .ALPHA.-TOCOPHEROL ACETATE WATER PEG-100 STEARATE STEARYL ALCOHOL GLYCOL STEARATE MENTHOL MENTHOL SODIUM LAURYL SULFATE GLYCERIN DIMETHICONE 1000 CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL PHENOXYETHANOL ALOE VERA LEAF LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE GLYCERYL STEARATE SE EUCALYPTUS GLOBULUS LEAF ROSEMARY OIL CHAMOMILE SALIX ALBA BARK CAPSICUM ANNUUM WHOLE XANTHAN GUM POLYSORBATE 20 GLUCOSAMINE SULFATE"
      ],
      "active_ingredient": [
        "Lidocaine HCl 4% Menthol 1%"
      ],
      "purpose": [
        "Topical Analgesic"
      ],
      "indications_and_usage": [
        "USES: For temporary local relief of minor pain in muscles or joints."
      ],
      "warnings": [
        "For external use only. Ask a doctor before use if you have redness over affected area."
      ],
      "when_using": [
        "Use only as directed. Avoid contact with eyes and mucous membranes. Do not bandage tightly or use with a heating pad. A transient burning sensation or redness may occur upon application but generally disappears in several days. Do not apply on large areas of the body or on damaged, broken, or irritated skin."
      ],
      "stop_use": [
        "STOP USE AND ASK A DOCTOR IF: Redness is present. Condition worsens. Irritation develops. Symptoms persist for more than 7 days or clear up and occur again within a few days. You experience signs injury, such as pain, swelling or blistering where the product was applied."
      ],
      "pregnancy_or_breast_feeding": [
        "Ask a health professional before use."
      ],
      "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 over 12 years of age Apply a small amount to the affected area. Massage in a circular motion, let set for a few seconds. Repeat as necessary, but no more than 3 to 4 times daily. Children under 12 years of age; do not use unless directed by doctor."
      ],
      "other_safety_information": [
        "Store at room temperature 15° - 30°C (59° - 86°F)"
      ],
      "inactive_ingredient": [
        "Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glycol Stearate, Stearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Sodium Lauryl Sulfate, Dimethicone, Glycerin, Caprylhydroxamic Acid, Caprylyl Glycol, Eucalyptus Globulus Leaf Oil, Phenoxyethanol, Methylpropanediol, Acrylamide/Sodium Acrylate Copolymer, Paraffinum Liquidum, Trideceth-6, Methylsulfonylmethane, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosmarinus Officinalis (Rosemary) Oil, Tocopheryl Acetate, Arnica Montana Flower Extract, Salix Alba Bark Extract, Glucosamine Sulfate, Chamomilla Recutita (Matricaria) Flower Extract, Capsicum Annuum Fruit Extract."
      ],
      "package_label_principal_display_panel": [
        "DZUL - LIDO CREME ROLL-ON LIDO CREME"
      ],
      "set_id": "063387e4-a1b1-a467-e063-6294a90a6cbd",
      "id": "47e61d24-653c-15d0-e063-6294a90a9312",
      "effective_time": "20260108",
      "version": "2",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "DZUL - LIDO CREME"
        ],
        "generic_name": [
          "LIDOCAINE HCL, MENTHOL"
        ],
        "manufacturer_name": [
          "Caball Sales, Inc."
        ],
        "product_ndc": [
          "83037-041"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LIDOCAINE HYDROCHLORIDE",
          "MENTHOL"
        ],
        "rxcui": [
          "2598162"
        ],
        "spl_id": [
          "47e61d24-653c-15d0-e063-6294a90a9312"
        ],
        "spl_set_id": [
          "063387e4-a1b1-a467-e063-6294a90a6cbd"
        ],
        "package_ndc": [
          "83037-041-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0850019307252"
        ],
        "unii": [
          "V13007Z41A",
          "L7T10EIP3A"
        ]
      }
    }
  ]
}