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
  • 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 December 26, 2022

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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 not finalpart34812/28/2022
    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)
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