Label: GEL COOLING PAIN RELIEF- menthol gel

  • NDC Code(s): 11344-894-18
  • Packager: Consumer Product Partners, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 16, 2024

If you are a consumer or patient please visit this version.

  • Active ingrident

    Menthol 4%

  • Purpose

    External analgesic

  • Uses

    for temporary relief from minor aches and pains of muscles & joints associated with

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

    For external use only

    Flammable, keep away from fire or flame.

  • When using this product

    • avoid contact with the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
  • Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor
  • Other information

    store in a cool dry place with lid closed tightly

  • Inactive ingredients

    Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, llex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5

  • Adverse reaction

    Distributed by: Consumer Product Partners, LLC

    St. Louis, MO 63114

    1-888-593-0593

  • Disclaimer

    *This product  is not manufactured or distributed by Reckitt Health Pain (US) LLC, distributor of BioFreeze® Cool the Pain® Colorless Roll-On Menthol Pain Relieving Gel*

  • Principal display panel

    swan®

    ROLL-ON COOLING PAIN RELIEF

    PAIN RELIEVING GEL

    soothing menthol

    • For arthritis, sore muscles, joints and back pain
    • Diminshing scent

    Compare to Biofreeze® Cool the Pain® Colorless Roll-On Menthol Pain Relieveing Gel*

    2.5 FL OZ (74 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    GEL COOLING PAIN RELIEF 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-894
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-894-1874 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/13/2021
    Labeler - Consumer Product Partners, LLC (119091520)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(11344-894)