Label: BIOFREEZE DAY AND OVERNIGHT- menthol kit

  • NDC Code(s): 59316-005-03, 59316-832-94, 59316-992-07
  • 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 May 24, 2023

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

  • Drug Facts

  • ACTIVE INGREDIENT

    Menthol 5%

    Pain Relieving Patch

  • Uses

    Temporarily relieves minor aches and pains of muscles and
    joints associated with:

    ■ simple backache

    ■ arthritis

    ■ strains
    ■ bruises

    ■ sprains

  • 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 breast-feeding:

    ask a health professional before use.

    Keep out of reach of children:

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    ■ adults and children 12 years of age and older: Clean and dry affected area,

    pop apart and partially peel back protective film and apply exposed patch to
    site of pain. Carefully remove remaining film while pressing the patch to skin
    and leave in place for up to 8 hours. Use on affected area not more than
    3 to 4 times daily.

    ■ children under 12 years of age: consult a physician

    ■wash hands after use with cool water

  • Other Information

    ■ store at 20-25°C (68-77°F)

    ■ store in a cool dry place away from direct sunlight

  • INACTIVE INGREDIENT

    Large Patch:

    1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower
    Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract,
    Carboxymethylcellulose Sodium, DihydroxyaluminumAminoacetate, Ethylhexylglycerin,
    Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum,
    Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol,
    PurifiedWater, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

    Overnight Relief Patch:

    Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum
    Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride,
    Lavender Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80,
    Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate,
    Tartaric Acid, Titanium Dioxide

  • Questions

    1-866-682-4639

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Menthol 5%

    Purpose:

    Pain Relieving Patch

  • PRINCIPAL DISPLAY PANEL

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    BIOFREEZE DAY AND OVERNIGHT 
    menthol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-832
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-832-941 in 1 KIT05/31/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 PATCH 18 g  in 3 
    Part 26 PATCH 54 g  in 6 
    Part 1 of 2
    BIOFREEZE OVERNIGHT RELIEF 
    menthol, unspecified form patch
    Product Information
    Item Code (Source)NDC:59316-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.3 g  in 6 g
    Inactive Ingredients
    Ingredient NameStrength
    LAURALKONIUM CHLORIDE (UNII: 07HUP5A29X)  
    TARTARIC ACID (UNII: W4888I119H)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    KAOLIN (UNII: 24H4NWX5CO)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-005-036 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/22/2023
    Part 2 of 2
    BIOFREEZE  MENTHOL
    menthol, unspecified form patch
    Product Information
    Item Code (Source)NDC:59316-992
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    KAOLIN (UNII: 24H4NWX5CO)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-992-071 in 1 POUCH
    19 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/22/2023
    Labeler - RB Health (US) LLC (081049410)