Label: BIOFREEZE- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2024

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  • Drug Facts

  • Active Ingredients:

    Menthol USP 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:

    • Avoid contact with the 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 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 four times daily; massage not necessary
    • Children under 12 years of age:Consult physician

  • Inactive Ingredients:

    Caprylic/Capric Triglyceride, Caprylyl Glycol, Alcohol, Dimethicone, Gluconolactone Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water,Calcium Gluconate, Cetostearyl Alcohol, Edetate Sodium, Isopropyl Alcohol, PEG-4 Laurate

  • Questions or Comments:

    1-800-246-3733

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BIOFREEZE 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-869
    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
    ALCOHOL (UNII: 3K9958V90M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    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:59316-869-1085 g in 1 JAR; Type 0: Not a Combination Product03/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/21/2020
    Labeler - RB Health (US) LLC (081049410)
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