Label: BIOFREEZE- menthol gel

  • NDC Code(s): 59316-101-10, 59316-101-11, 59316-101-12, 59316-101-13, view more
    59316-101-15, 59316-101-19, 59316-101-20, 59316-101-21, 59316-101-25, 59316-101-30, 59316-101-40, 59316-101-50
  • 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 February 24, 2022

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  • Active Ingredients

    Menthol USP 3.5%

  • Purpose

    Cooling Pain Reliever

  • Uses

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

  • 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 damaged 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 recur.

    If pregnant or breastfeeding:

    Ask a health professional before use.

    Keep out of the reach of children:

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

  • Directions

    • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
    • Children under 2 years of age : Consult physician
  • Other Information:

    Store in a cool dry place with lid closed tightly

  • Inactive ingredients

    • carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water USP
  • Questions or Comments?

    800-246-3733

  • PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label

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

    BIOFREEZE®
    PAIN RELIEVING Roll-On

    WITH SOOTHING MENTHOL

    Cryotherapy - The Cold Method®

    3 fl oz / 89 mL

    PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label
  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump Label

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

    BIOFREEZE®
    PAIN RELIEVING gel

    WITH SOOTHING MENTHOL

    Cryotherapy - The Cold Method®

    16 fl oz / 473 mL

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump Label
  • INGREDIENTS AND APPEARANCE
    BIOFREEZE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-101-105 mL in 1 PACKET; Type 0: Not a Combination Product08/25/2016
    2NDC:59316-101-1589 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/25/2016
    3NDC:59316-101-20118 mL in 1 TUBE; Type 0: Not a Combination Product08/25/2016
    4NDC:59316-101-2181 mL in 1 TUBE; Type 0: Not a Combination Product08/25/201612/31/2018
    5NDC:59316-101-30473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
    6NDC:59316-101-40946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
    7NDC:59316-101-503785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
    8NDC:59316-101-25118 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product08/25/201612/31/2021
    9NDC:59316-101-1259 mL in 1 TUBE; Type 0: Not a Combination Product08/25/2016
    10NDC:59316-101-1359 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/25/2016
    11NDC:59316-101-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2016
    12NDC:59316-101-193 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/25/2016
    Labeler - RB Health (US) LLC (081049410)
    Establishment
    NameAddressID/FEIBusiness Operations
    Span Packaging Services dba Multi-Pack Solutions117101131manufacture(59316-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Span Packaging Services dba Multi-Pack Solutions557434805manufacture(59316-101)
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