Label: LIDOCAINE PAIN RELIEF GEL-PATCH- lidocaine patch

  • NDC Code(s): 83602-158-01, 83602-158-18
  • Packager: Guangzhou Liuquanmiao Import & Export Trade 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 August 5, 2023

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  • Active ingredients

    Lidocaine 4% ...... Purpose: Topical Analgesic

  • Purpose

    Topical Analgesic

  • 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 ... 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 above 12 years old:

    • Clean and dry the affected area.
    • Tear off the proctive 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

    Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

  • Usage

    Usage

  • Questions or Comments

    sumifunofficial@gmail.com

  • Package label. Principal display panel

    Label_boxLabel_bag

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PAIN RELIEF GEL-PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83602-158
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    KAOLIN (UNII: 24H4NWX5CO)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83602-158-1818 in 1 BOX08/08/2023
    1NDC:83602-158-0112 g in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/08/2023
    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(83602-158) , label(83602-158)
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