Label: PAIN RELIEVING GEL-PATCH- lidocaine patch

  • NDC Code(s): 73557-157-01, 73557-157-05, 73557-157-15, 73557-157-18
  • Packager: Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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  • Active ingredient

    Lidocaine 4% ...... Purpose: Topical Anesthetic

  • Purpose

    Topical Anesthetic

  • Uses

    For temporary relief of pain

  • Warnings

    For external use only

  • Ask a doctor if:

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Conditions worsen
    • Symptoms persists for more than 7 days
    • Symptoms clear up and occur again within a few days
  • When using this product

    • Use only as directed
    • Avoid contact with the eyes, mucous membranes or rashed
    • Do not bandage tightly
  • Do not use

    • More than 1 patch at a time
    • On wounds or damaged skin
    • With a heating pad
    • If you are allergic to any ingredients of this product
  • Stop use if:

    • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Conditions worsen
    • Symptoms persists for more than 7 days
    • Symptoms clear up and occur again within a few days
  • Pregnancy or breast feeding

    If pregnant or breastfeeding, ask a health professional before use

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adult and Children 12 years of age and over:

    • Clean and dry affected area
    • Remove film from patch and apply to the skin (see illustration)
    • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
    • Remove patch from the skin after at most 8-hour application

    Children under 12 years of age: Consult a doctor

  • Dosage forms & strengths

    This is a strip, patch dosage form.

    The active ingredient strength is 4% w/w.

    One patch one time, no more than 8 hours one time.

  • Inactive ingredients

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

  • Questions or Comments?

    1 646-223-0128 · Lu.FDAmanage@gmail.com

  • Other information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
  • Package label. Principal display panel

    01051518

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING GEL-PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-157
    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
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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:73557-157-055 in 1 BOX12/30/2022
    1NDC:73557-157-0112 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:73557-157-1515 in 1 BOX01/09/2024
    2NDC:73557-157-0112 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:73557-157-1818 in 1 BOX01/09/2024
    3NDC:73557-157-0112 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/30/2022
    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(73557-157) , label(73557-157)
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