Label: BIOFREEZE PAIN RELIEF- menthol, unspecified form cream

  • 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 December 20, 2021

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  • Drug Facts

  • Active Ingreidents

    Menthol 10%

    Purpose

    Cooling Pain Relief

  • Uses

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

  • Warnings

    For external use only.

    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 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 breat-feeding:

    Ask a health professional before use

    Keep out of reach of children:

    If accidentally ingested, get medical help or contact a Poison Contropl 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.
    • Childern under 12 years of age:  Consult physician
  • Inactive Ingredients

    Caprylic/Capric Triglyceride, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Ilex Paraguariensis Leaf Extract, Iodopropynyl butylcarbamate, 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:

    Label10Label11

  • INGREDIENTS AND APPEARANCE
    BIOFREEZE PAIN RELIEF 
    menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-307
    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 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRICAPRIN (UNII: O1PB8EU98M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    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:59316-307-101 in 1 CARTON03/07/201812/31/2024
    189 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/07/201812/31/2024
    Labeler - RB Health (US) LLC (081049410)
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