Label: PAIN RELIEF GEL-PATCH- lidocaine and menthol patch

  • NDC Code(s): 83602-172-01, 83602-172-15
  • Packager: Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • Active ingredients

    Lidocaine 4% ...... Purpose: Topical anesthetic

    Menthol 1% ...... Purpose: Topical analgesic

  • Purpose

    Topical anesthetic (Lidocaine)

    Topical analgesic (Menthol)

  • Uses

    Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, 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 and 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

    Adult and Children above 12 years old:

    • Clean and dry the affected area.
    • Tear off the protective film and apply the exposed part of the patch to the affected area.
    • Carefully remove remaining film while pressing the patch firmly on the skin.
    • Remove patch from the skin after at most 8-hour application.

    Children under age of 12: Consult a doctor

  • Inactive ingredients

    Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water.

  • Questions or Comments:

    sumifunofficial@gmail.com

  • Package label. Principal display panel

    0115

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF GEL-PATCH 
    lidocaine and menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83602-172
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.01 g  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    KAOLIN (UNII: 24H4NWX5CO)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83602-172-1515 in 1 BOX11/28/2023
    1NDC:83602-172-0112 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/28/2023
    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(83602-172) , label(83602-172)
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