Label: BIOFREEZE MENTHOL- menthol, unspecified form kit

  • NDC Code(s): 59316-887-04, 59316-992-32, 59316-992-33
  • 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 September 30, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 5%

  • Purpose

    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 ingredients

    Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Cellulose Gum, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Phenoxyethanol, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • Questions or comments?

    1-800-246-3733

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US)
    Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    CLINICALLY
    RECOMMENDED*

    NDC 59316-887-04

    BiOFREEZE®
    COOL THE PAIN

    EXTRA LARGE
    PATCHES

    MENTHOL-PAIN
    RELIEVING PATCH

    Designed to provide up to
    8 hours of long lasting pain relief

    Proven cold therapy formula for sore
    muscles, simple backaches, and joint pain

    Flexible fabric for superior performance and comfort

    4 PATCHES | 2 SIZES
    EXTRA LARGE
    AND LONG

    2 EXTRA LARGE 9.84 in x 5.5 in (25 cm x 14 cm) each
    2 LONG 7.87 in x 3.94 in (20 cm x 10 cm) each

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    BIOFREEZE   MENTHOL
    menthol, unspecified form kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-887
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-887-041 in 1 KIT03/10/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PATCH 20 g
    Part 21 PATCH 13 g
    Part 1 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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Carboxymethylcellulose sodium, unspecified (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Petrolatum (UNII: 4T6H12BN9U)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-992-321 in 1 POUCH
    120 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 finalpart34803/10/2022
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Carboxymethylcellulose sodium, unspecified (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Petrolatum (UNII: 4T6H12BN9U)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-992-331 in 1 POUCH
    113 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 finalpart34803/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/10/2022
    Labeler - RB Health (US) LLC (081049410)
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