Label: BIOFREEZE COLORLESS- menthol gel

  • NDC Code(s): 59316-103-10, 59316-103-11, 59316-103-12, 59316-103-15, view more
    59316-103-20, 59316-103-28, 59316-103-40
  • Packager: Performance Health LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 27, 2021

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients:


    Menthol USP 4%

    Purpose

    Cooling Pain Relief

  • Uses:

    Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • backache • strains • 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:

    • Use only as directed • Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin • Wash hands after use with cool water • Do not bandage or use with heating pad or device • Store in a cool dry place away from direct sunlight

    Stop use and ask a doctor if:

    You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

    If pregnant or breastfeeding:

    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 than 4 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, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water

  • Questions or Comments

    1-800-246-3733

  • Package Labeling: 59316-103-40

    Label

  • Package Labeling:59316-103-12

    Label7

  • Package Labeling:59316-103-20

    Label.8

  • INGREDIENTS AND APPEARANCE
    BIOFREEZE COLORLESS 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-103-40946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
    2NDC:59316-103-105 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/201212/31/2014
    3NDC:59316-103-113 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/201212/31/2021
    4NDC:59316-103-1589 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/03/201212/31/2018
    5NDC:59316-103-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2012
    6NDC:59316-103-1289 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/2016
    7NDC:59316-103-28273 mL in 1 BOTTLE; Type 0: Not a Combination Product09/19/201612/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/03/2012
    Labeler - Performance Health LLC (794324061)