Label: BIOFREEZE PROFESSIONAL- menthol, unspecified form spray

  • NDC Code(s): 59316-120-20, 59316-120-30
  • 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 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 10.5%

  • Purpose

    Pain Relieving Spray

  • Uses

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

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only.

    Flammable: Keep away from excessive heat or open flame

    Contents under pressure. Do not puncture or incinerate.

    Do not store at temperature above 120°F.

    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: spray on to affected area not more than 3 to 4 times daily; massage not necessary
    • 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

    Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

  • Questions or comments?

    1-800-246-3733

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    CLINICALLY
    RECOMMENDED*

    NDC 59316-120-20

    BiOFREEZE®
    PROFESSIONAL

    SPRAY
    MENTHOL-PAIN
    RELIEVING SPRAY

    4 FL OZ (118 mL)

    360°
    SPRAY

    PRESS DOWN FIRMLY TO
    ACTIVATE SPRAYER FOR FIRST USE

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BIOFREEZE PROFESSIONAL 
    menthol, unspecified form spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM105 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-120-30473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2016
    2NDC:59316-120-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/03/2016
    Labeler - RB Health (US) LLC (081049410)
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