Label: BIOFREEZE PROFESSIONAL- menthol, unspecified form gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 6, 2024

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  • Drug Facts

  • Active Ingredients:

    Menthol USP 5%

    Purpose

    Cooling Pain Relief

  • Uses:

    Temporary relief from minor aches and pains of sore muscles and joints associated with arthiritis, backache, strains and sprains

  • Warnings:

    For external use only

    Flammable: Keep away from excessive heat or open flame

    Ask a doctor before use if you have:

    Sensitive skin

    When using this product:

    Avoid contact with the eyes or mucous membranes; Do not apply to wounds or damaged skin; Do not use with other ointments, creams, sprays or liniment; Do not apply to irritated skin or if excessive irritation develops; Do not bandage; Wash hands after use with cool water; Do not use with heating pad or device; Store in cool dry place

    Stop use and ask a doctor If:

    Condition worsens, or if symptoms persist for more than 7 days , or clear up and recur

    If pregnant or breast-feeding:

    Ask a health professional before use

    Keep out of reach of children:

    If accidentally ingested, get medical help or contact a Poison Control Center immediately

  • Directions:

    Adults and Children 2 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary Children under 2 years of age: Consult physician

  • Inactive Ingredients:

    Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

  • Questions or Comments:

    1-800-246-3733

  • Package Labeling:

    PDP

  • INGREDIENTS AND APPEARANCE
    BIOFREEZE PROFESSIONAL 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4325(NDC:59316-115)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-4325-4120 mL in 1 TUBE; Type 0: Not a Combination Product03/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00406/03/2016
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-4325)
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