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

  • NDC Code(s): 73557-172-01, 73557-172-05, 73557-172-10, 73557-172-15
  • 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% w/w ...... Purpose: Topical anesthetic

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

  • Purposes

    Topical anesthetic (Lidocaine)

    Topical analgesic (Menthol)

  • Uses

    For temporary relief of pain

  • Warnings

    For external use only

  • When using this product:

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

    • More than 1 patch at a time
    • On wounds or damaged skin
    • For more than one week without consulting a doctor
    • If you are allergic to any ingredients of this product
  • Stop use and ask a doctor if:

    • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Condition worsen
    • Symptoms persist for more than 7 days
    • Symptoms 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 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

  • Inactive Ingredients

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

  • Questions or Comments

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

  • Other information

    • Store at 68-77℉ (20-25℃)
    • Store in a cool dry place away from direct sunlight
  • Package label. Principal display panel

    01051015

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF GEL-PATCH 
    lidocaine and menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-172
    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:73557-172-055 in 1 BOX12/30/2022
    1NDC:73557-172-0112 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:73557-172-1010 in 1 BOX01/09/2024
    2NDC:73557-172-0112 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:73557-172-1515 in 1 BOX01/09/2024
    3NDC:73557-172-0112 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph 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(73557-172) , label(73557-172)
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