{
  "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": "2026-10-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "FREEZE EASE Roll-On MENTHOL GLYCERYL MONOSTEARATE ARNICA MONTANA WHOLE GREEN TEA LEAF LEMON OIL, COLD PRESSED ISOPROPYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE BOSWELLIA SACRA WHOLE .ALPHA.-TOCOPHEROL ACETATE TROLAMINE WATER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Manufactured for: GAG GLOBAL AMERICA GROUP Global America Group LLC Brooklyn, NY 11201"
      ],
      "active_ingredient": [
        "Active ingredient Menthol 4%"
      ],
      "purpose": [
        "Purpose Topical analgesic"
      ],
      "indications_and_usage": [
        ""
      ],
      "warnings": [
        "Warnings For external use only. Flammable: Keep away from excessive heat or open flame. When using this product use only as directed avoid contact with the theeyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device Stop use and ask a doctor if you experience pain, swelling or blistering of the skin condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days arthritis pain persists for more than 10 days, or rednessis present. allergic reaction occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help orcontact a Poison Control Center right away."
      ],
      "when_using": [
        "When using this product use only as directed avoid contact with the theeyes or on mucous membranes do not apply to wounds or damaged skin do not apply to irritated skin or if excessive irritation develops do not bandage tightly or use with heating pad or device"
      ],
      "stop_use": [
        "Stop use and ask a doctor if you experience pain, swelling or blistering of the skin condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days arthritis pain persists for more than 10 days, or rednessis present. allergic reaction occurs If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help orcontact a Poison Control Center right away."
      ],
      "keep_out_of_reach_of_children": [
        ""
      ],
      "dosage_and_administration": [
        "Directions adults and children 5 years of age and older: apply externally to the affected area up to 3 to 4 times daily children under 5 years of age: consult a physician wash hands after use with cool water"
      ],
      "storage_and_handling": [
        "Other information may be applied under occlusive dressing store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature."
      ],
      "inactive_ingredient": [
        "Inactive ingredients GLYCERIN MONOSTEARATE ACETATE, ARNICA MONTANA FLOWER EXTRACT, GREEN TEA LEAF EXTRACT, LEMON OIL, ISOPROPYL ALCOHOL, CARBOMER, HOMOPOLYMER, BEESWAX, CASTOR OIL, ALPHA-TOCOPHEROL ACETATE, TROLAMINE, WATER."
      ],
      "questions": [
        "Questions or comments? 646-457-4800"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label NDC:87843-311-50 FREEZE EASE MENTHOL 4% ROLL-ON COOLING PAIN RELIEF GEL 50 mL Principal Display Panel - 50 mL Bottle Label"
      ],
      "set_id": "1869cc0d-a056-45de-aede-23b09b61ed12",
      "id": "1a5acf8d-9065-47fc-bcb9-15881e5e3700",
      "effective_time": "20260902",
      "version": "1",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "FREEZE EASE Roll-On"
        ],
        "generic_name": [
          "MENTHOL"
        ],
        "manufacturer_name": [
          "Global America Group LLC"
        ],
        "product_ndc": [
          "87843-311"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL, UNSPECIFIED FORM"
        ],
        "rxcui": [
          "415974"
        ],
        "spl_id": [
          "1a5acf8d-9065-47fc-bcb9-15881e5e3700"
        ],
        "spl_set_id": [
          "1869cc0d-a056-45de-aede-23b09b61ed12"
        ],
        "package_ndc": [
          "87843-311-50"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "L7T10EIP3A"
        ]
      }
    }
  ]
}