Label: BIOFREEZE- menthol spray

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

Drug Label Information

Updated February 1, 2024

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  • Drug Facts


  • Active Ingredients:

    Menthol 10.5%

    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.

    Flammable:

    Keep away from excessive heat or open flame.

    Contents Under Pressure. Do Not Punture Or Incinerate Do Not Store At Temperature Above 120°F

    Ask a Doctor Before using If You have:

    ■ 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

    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 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 12 years of age and older:Spray on to the affected areas not more than 4 times daily; massage not necessary
    Children under 12 years of age:Consult physician

  • Inactive Ingredients

    Alcohol, Arnica Montana Flower Extract, Calendula Officinalis
    Flower Oil, Camellia Sinensis Leaf Oil, Chamomilla Recutita
    (Matricaria) Flower Extract, Denatonium Benzoate, Echinacea
    Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract,
    Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis
    Fruit Extract, Methylsulfonylmethane, Purified Water,
    Tert-Butyl Alcohol

  • Questions or Comments:

    1-800-246-3733

  • Package Labeling:

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    BIOFREEZE 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-833
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL105 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ALCOHOL (UNII: 3K9958V90M)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    WATER (UNII: 059QF0KO0R)  
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8)  
    TEA LEAF OIL (UNII: VC855RRT77)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-833-1089 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/01/2023
    Labeler - RB Health (US) LLC (081049410)
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