Label: BIOFREEZE FLEXIBLE RELIEF STRIP- menthol patch

  • NDC Code(s): 59316-004-01, 59316-004-04
  • 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 January 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 5.6%

  • 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.
    • do not stretch the patch during application as it should be comfortable and not tight
    • do not overwrap or wrap patches over themselves
    • for best adhesion: area should be clean, dry, and smooth
    • 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, Benzalkonium Chloride, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Isopropyl Myristate, Kaolin, L-Tartaric Acid, Lauralkonium Chloride, Mineral Oil, Nonoxynol-10, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, 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 - 4 Strip Carton

    CLINICALLY
    RECOMMENDED*

    NDC 59316-004-04

    BiOFREEZE®
    COOL THE PAIN

    FLEXIBLE
    RELIEF
    STRIPS
    MENTHOL-PAIN
    RELIEVING PATCH

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

    Strong adhesion to stay
    through any movement

    Optimal thickness for
    comfort and flexiblity

    4 STRIPS |
    EXTRA
    LONG

    10 in x 2 in
    (25.4 cm x 5 cm) each

    PRINCIPAL DISPLAY PANEL - 4 Strip Carton
  • INGREDIENTS AND APPEARANCE
    BIOFREEZE FLEXIBLE RELIEF STRIP 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM56 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    TARTARIC ACID (UNII: W4888I119H)  
    LAURALKONIUM CHLORIDE (UNII: 07HUP5A29X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-004-011 in 1 POUCH03/31/2021
    16 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:59316-004-044 in 1 CARTON03/31/2021
    26 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 finalpart34803/31/2021
    Labeler - RB Health (US) LLC (081049410)
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