Label: BIOFREEZE ROLL-ON- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 March 26, 2021

If you are a healthcare professional or from the pharmaceutical industry 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:

    • 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 or if excessive skin irritation develops.
    • Do not bandage
    • Wash hands after use with cool water
    • Do not use with heating pad or device.
    • Store in a 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 than 4 times daily; massage not necessary
    Children under 2 years of age: Consult physician

  • Inactive Ingredients:

    Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Arctium Lappa Root (Burdock) Extract, Boswellia Carteril Resin Extract, Calendula Officinallis Extract, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Camphor USP, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Ispropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silicon Dioxide, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Purified Water USP, Blue 1, Yellow 5

  • Questions or Comments

    1-800-246-3733

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Biofreeze Roll-On

    GENERIC: MENTHOL

    DOSAGE: GEL

    ADMINSTRATION: TOPICAL

    NDC: 70518-0485-0

    PACKAGING: 74 mL in 1 BOTTLE

    ACTIVE INGREDIENT(S):

    • MENTHOL 40mg in 1mL

    INACTIVE INGREDIENT(S):

    • ALOE VERA LEAF
    • ARNICA MONTANA FLOWER
    • FRANKINCENSE
    • CALENDULA OFFICINALIS FLOWER
    • GREEN TEA LEAF
    • GLYCERIN
    • ILEX PARAGUARIENSIS LEAF
    • ISOPROPYL ALCOHOL
    • ISOPROPYL MYRISTATE
    • MELISSA OFFICINALIS LEAF
    • SILICON DIOXIDE
    • .ALPHA.-TOCOPHEROL ACETATE
    • TROLAMINE
    • WATER
    • FD&C BLUE NO. 1
    • FD&C YELLOW NO. 5

    MM1

  • INGREDIENTS AND APPEARANCE
    BIOFREEZE ROLL-ON 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0485(NDC:59316-205)
    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)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-0485-074 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/05/2017
    Labeler - REMEDYREPACK INC. (829572556)