Label: BIOFREEZE- menthol spray

  • NDC Code(s): 59316-104-10, 59316-104-20, 59316-104-25, 59316-104-30
  • Packager: RB Health (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • Drug Facts

  • Active Ingredients:

    Menthol USP 10%

    Purpose

    Cooling Pain Reliever

  • Uses:

    Temporary relief from minor aches and pains of sore muscles and joints associated with: -arthritis - backache - strains - sprains

  • Warnings:

    For external use only

    Flammable: Keep away from excessive heat or open flame

    Ask a doctor before use if you have:

    sensitive skin

    When Using This Product:

    -Avoid contact with the eyes or mucous membranes - Do not apply to wounds or damages skin -Do not use with other ointments, creams, sprays or liniments -Do not apply to irritated skin or if excessive irritation develops -Do not bandage - Wash hands after use with cool water -Do not use with heating pad or device

    Stop Use And Ask A Doctor If:

    Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

    If pregnant or breastfeeding:

    Ask a health professional before use.

    Keep out of reach of children:

    If accidentally ingested, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 12 years of age and older:Spray on to the affected areas not more than 4 times daily; massage not necessary.

    Children under 12 years of age:Consult a physician

  • Other Information:

    Store in a cool dry place with lid closed tightly

  • Inactive Ingredients:

    Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone, Echinacea, Ethanol,  ilex Paraguarenis, Isopropyl Myristate, Juniper Berry, water, White Tea

  • Questions or Comments?

    1-800-246-3733

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    PENETRATING, LONG LASTING PAIN RELIEF FROM:
    ARTHRITIS • SORE MUSCLES & JOINTS • BACK PAIN

    BIOFREEZE ®
    PAIN RELIEVING Spray

    WITH SOOTHING MENTHOL

    Cryotherapy - The Cold Method ®

    16 fl. oz./473mL

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BIOFREEZE 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    ALCOHOL (UNII: 3K9958V90M)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-104-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/25/2016
    2NDC:59316-104-20118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/25/2016
    3NDC:59316-104-30473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/25/2016
    4NDC:59316-104-25118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/29/201212/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/01/2010
    Labeler - RB Health (US) LLC (081049410)
    Establishment
    NameAddressID/FEIBusiness Operations
    Span Packaging services LLC dba Multi-Pack Solutions117101131manufacture(59316-104)
    Establishment
    NameAddressID/FEIBusiness Operations
    Span Packaging Services LLC dba Multi-Pack Solutions557434805manufacture(59316-104)
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