Label: MENTHOL PAIN RELIEF GEL-TUBE- menthol gel

  • NDC Code(s): 83602-323-30
  • Packager: Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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

  • Active ingredient

    Menthol 4% ...... Purpose: Topical Analgesic

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, ankle, back, neck, hips, shoulders, elbows.

  • Warnings

    For external use only

  • Do not use

    • on wounds or damaged skin

    • with a heating pad or device

    • with other ointments, creams, sprays, or liniments

    • if you are allergic to any ingredients of this product

  • When using this product

    • use only as directed

    • avoid contact with the eyes, mucous membranes, or rashes

    • do not bandage tightly

  • Stop use ... if

    • skin reactions such as redness, swelling, blistering or other discomfort occur

    • symptoms persist for more than 7 days

  • ... ask a doctor if

    • skin reactions such as redness, swelling, blistering or other discomfort occur

    • symptoms persist for more than 7 days

  • If pregnant or breast-feeding,

    Ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN.

    If swallowed accidentally, get medical help or contact with Poison Control Center immediately.

  • Directions

    Adults and children 12 years of age and older:

    • Rub a thin film over affected areas not more than 4 times daily;

    • Message not necessary

    Children under 12 years of age: Consult physician.

    Wash hands after use with cool water.

  • Inactive ingredients

    Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Silica, Triethanolamine, Vitamin E, Water

  • Questions or Comments:

    sumifunofficial@gmail.com

  • PRINCIPAL DISPLAY PANEL

    Container LabelPackage Label

  • INGREDIENTS AND APPEARANCE
    MENTHOL PAIN RELIEF GEL-TUBE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83602-323
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.04 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL 95% (UNII: 7528N5H79B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83602-323-3089 mL in 1 TUBE; Type 0: Not a Combination Product12/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/06/2023
    Labeler - Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. (418399704)
    Registrant - Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. (418399704)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(83602-323) , label(83602-323)