Label: PAIN RELIEF GEL-TUBE- menthol gel

  • NDC Code(s): 73557-323-30
  • Packager: Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 29, 2024

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  • Active Ingredient

    Menthol 4.0% w/w ...... Purpose: Topical Analgesic

  • Purpose

    Topical Analgesic

  • Uses

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

    Use only as directed • Avoid contact with 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 • Wash hands after use with cool water • Do not bandage or use with heating pad or device • Store in a cool dry place away from direct sunlight

  • DO NOT USE

    • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays, or liniments • Do not apply to irritated skin • Do not bandage or use with heating pad or device

  • Stop use and ask a doctor if

    You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

  • If pregnant or breast-feeding

    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: Rub a thin film over affected areas not more than 4 times daily; message not necessary

    Children under 12 years of age: Consult physician

  • 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, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

  • Questions or Comments

    86-21-31166566

  • PRINCIPAL DISPLAY PANEL

    Container LabelPackage Label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF GEL-TUBE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-323
    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:73557-323-3089 mL in 1 TUBE; Type 0: Not a Combination Product12/28/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/28/2022
    Labeler - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
    Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(73557-323) , label(73557-323)