Label: BIOFREEZE FOOT PAIN RELIEF SET- menthol kit

  • NDC Code(s): 59316-001-10, 59316-002-10
  • Packager: RB Health (US) 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 February 23, 2022

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  • Drug Facts

  • Active ingredient:

    Menthol 10%

    Purpose

    Pain Relieving Cream

  • Uses:

    Temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises

  • Warnings

    For external use only

    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 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 right away

  • Directions:

    • Adults and Children 12 years of age and older: Rub a thin film over affected areas not more than 3 to 4 times daily;
    • Children under 12 years of age: Consult a physician
    • wash hands after use with cool water

  • 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

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Kit

    NDC 59316-002-10

    BiOFREEZE®
    COOL THE PAIN

    FOOT PAIN
    RELIEF SET

    MENTHOL-PAIN
    RELIEVING CREAM

    FOOT ROLLER intended to
    relieve foot pain and pain associated
    with plantar fasciitis

    1 Biofreeze Foot Cream Tube
    Net wt 3 OZ (85 g)
    + 1 Foot Roller

    PRINCIPAL DISPLAY PANEL - 85 g Tube Kit
  • 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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 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 - RB Health (US) LLC (081049410)
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