Label: BIOFREEZE FOOT PAIN RELIEF SET- menthol kit

  • NDC Code(s): 59316-001-10, 59316-002-10
  • 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 March 15, 2021

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

  • Drug Facts

  • Active ingredients:

    Menthol 10%

    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

    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 12 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
    Children under 12 years of age: Consult physician

  • Inactive ingredients:

    Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

  • Questions or comments:

    1-800-246-3733

  • Package Labeling:Kit

    KIT

  • Package Labeling:59316-001-10

    Tube

  • INGREDIENTS AND APPEARANCE
    BIOFREEZE FOOT PAIN RELIEF SET 
    menthol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-002
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-002-101 in 1 KIT03/12/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 85 g
    Part 1 of 1
    BIOFREEZE FOOT CREAM 
    menthol cream
    Product Information
    Item Code (Source)NDC:59316-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-001-1085 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/12/2021
    Labeler - Performance Health LLC (794324061)