{
  "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,
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      "total": 118
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "Biofreeze Professional MENTHOL, UNSPECIFIED FORM ALCOHOL ARNICA MONTANA FLOWER CALENDULA OFFICINALIS FLOWER TEA LEAF OIL CHAMOMILE DIMETHYL SULFONE ECHINACEA ANGUSTIFOLIA WHOLE ILEX PARAGUARIENSIS LEAF ISOPROPYL MYRISTATE JUNIPER BERRY WATER MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM DENATONIUM BENZOATE GLYCERIN TERT-BUTYL ALCOHOL ISOPROPYL ALCOHOL"
      ],
      "spl_unclassified_section": [
        "Drug Facts",
        "Dist. by: RB Health (US), Parsippany, NJ 07054-0224"
      ],
      "active_ingredient": [
        "Active ingredient Menthol 10.5%"
      ],
      "purpose": [
        "Purpose Pain Relieving Spray"
      ],
      "indications_and_usage": [
        "Uses Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains"
      ],
      "warnings": [
        "Warnings For external use only. Flammable: Keep away from excessive heat or open flame Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. When using this product use only as directed avoid contact with the eyes 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 arthritic pain persists for more than 10 days, or redness is present If pregnant 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."
      ],
      "when_using": [
        "When using this product use only as directed avoid contact with the eyes 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 arthritic pain persists for more than 10 days, or redness is present"
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "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 12 years of age and older: spray on to affected area not more than 3 to 4 times daily; massage not necessary children under 12 years of age: consult a physician wash hands after use with cool water"
      ],
      "storage_and_handling": [
        "Other information store at 20-25°C (68-77°F) store in a cool dry place away from direct sunlight"
      ],
      "inactive_ingredient": [
        "Inactive ingredients Alcohol, Arnica Montana Flower Extract, Calendula Officinalis Flower Oil, Camellia Sinensis Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Denatonium Benzoate, Echinacea Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis Fruit Extract, Methylsulfonylmethane, PurifiedWater, Tert-Butyl Alcohol"
      ],
      "questions": [
        "Questions or comments? 1-800-246-3733"
      ],
      "package_label_principal_display_panel": [
        "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label CLINICALLY RECOMMENDED* NDC 59316-834-20 BiOFREEZE ® PROFESSIONAL SPRAY MENTHOL-PAIN RELIEVING SPRAY 4 FL OZ (118 mL) 360° SPRAY PRESS DOWN FIRMLY TO ACTIVATE SPRAYER FOR FIRST USE Label"
      ],
      "set_id": "00bba5d2-b0e0-701c-e063-6294a90a5741",
      "id": "51e066bd-7c9d-326a-e063-6394a90a28b1",
      "effective_time": "20260515",
      "version": "15",
      "openfda": {
        "application_number": [
          "M017"
        ],
        "brand_name": [
          "Biofreeze Professional"
        ],
        "generic_name": [
          "MENTHOL, UNSPECIFIED FORM"
        ],
        "manufacturer_name": [
          "Reckitt Benckiser LLC"
        ],
        "product_ndc": [
          "59316-834"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "MENTHOL, UNSPECIFIED FORM"
        ],
        "rxcui": [
          "1489073",
          "1489074"
        ],
        "spl_id": [
          "51e066bd-7c9d-326a-e063-6394a90a28b1"
        ],
        "spl_set_id": [
          "00bba5d2-b0e0-701c-e063-6294a90a5741"
        ],
        "package_ndc": [
          "59316-834-20",
          "59316-834-22"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0359316120200"
        ],
        "unii": [
          "L7T10EIP3A"
        ]
      }
    }
  ]
}