Label: PAIN RELIEF GEL-ROLL ON- lidocaine and menthol gel

  • NDC Code(s): 73557-373-25
  • Packager: Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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

  • Active Ingredient

    Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)

    Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

  • Purpose

    (Lidocaine) Topical Anesthetic

    (Menthol) Topical Analgesic

  • Use

    temporary relief of pain

  • Warnings

    For external use only

  • Do not use

    • on large areas of the body or on cut, irritated or swollen skin not apply to wounds or damaged skin • on puncture wounds • for more than one week without consulting a doctor

  • When using this product

    • use only as directed. Read and follow all directions and warnings on this label • do not allow contact with eyes and mucous membranes • do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use • do not use at the same time as other topical analgesics

  • Stop use if

    • condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days

  • Ask a doctor if

    • condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days

  • Flammable

    • keep away from fire or flame

  • If pregnant or breast-feeding

    Ask a health professional before use

  • Keep out of reach of children

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

  • Directions

    Adults and children 12 over years:

    • apply a thin layer to affected area 6 to 8 hours, not to exceed 3 application in a 24 hour period

    Children under 12 years of age: Consult a doctor

  • Inactive Ingredients

    Aloe Vera Extract, Carbopol, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water

  • Questions or Comments

    86-21-31166566

  • GENERAL PRECAUTIONS

    Child-resistant packaging. Close cap tightly after use.

  • PRINCIPAL DISPLAY PANEL

    Container LabelPackage Label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF GEL-ROLL ON 
    lidocaine and menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-373
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.01 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    WATER (UNII: 059QF0KO0R)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73557-373-2573 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/22/2022
    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(73557-373) , label(73557-373)