Label: BIOFREEZE OVERNIGHT RELIEF- menthol, unspecified form patch

  • NDC Code(s): 59316-005-03, 59316-005-04
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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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 symptons 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° (68-77°F)
    • store in a cool dry place away from direct sunlight
  • Inactive ingredients

    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 or comments?

    1-866-682-4639

  • SPL UNCLASSIFIED SECTION

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

    Made in China

  • PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Carton

    CLINICALLY
    RECOMMENDED

    NDC 59316-005-04

    BIOFREEZE ®
    COOL THE PAIN

    OVERNIGHT
    RELIEF
    PATCHES

    MENTHOL-TOPICAL
    ANALGESIC

    Overnight pain relief patch
    Scented with lavender
    essential oil

    Designed to stay on
    through the night

    Optimal thickness is designed for comfort and flexibility

    4 PATCHES

    5.125 in x 2.6 in
    (13 cm x 6.6 cm) each

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    BIOFREEZE OVERNIGHT RELIEF 
    menthol, unspecified form patch
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    LAURALKONIUM CHLORIDE (UNII: 07HUP5A29X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    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.)02/01/2022
    2NDC:59316-005-044 in 1 CARTON02/01/2022
    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 DrugM01702/01/2022
    Labeler - RB Health (US) LLC (081049410)
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