Label: TOPCARE PAIN RELIEF PATCH- lidocaine, menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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

  • Active ingredients

    Lidocaine 4%

    Menthol 1%

  • Purposes

    Topical anesthetic

    Topical analgesic

  • Use

    for the temporary relief of pain

  • Warnings

    For external use only

  • Do not use

    • more than 1 patch on your body at a time
    • On cut, irritated, or swollen skin
    • on puncture wounds
    • For more than one week without consulting a doctor
    • If you are allergic to any active or inactive ingredients
    • if pouch is damaged or opened
  • When using this product

    • use only as directed
    • Read and follow all directions and warnings on this carton
    • Do not allow contact with the eyes
    • Do not use at the same time as other topical analgesics
    • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • Do not microwave
    • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
  • Stop use and ask a doctor if

    • condition worsens
    • Redness is present
    • Irritation develops
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children and pets.

    If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

  • Directions

    adults and children 12 years of age and over:

    • clean and dry affected area
    • carefully remove backing from patch starting at a corner.
    • Appli sticky side of patch to affected area.
    • Use one patch for up to 12 hours
    • Dispatch patch after a single use.
    • children under 12 years of age: consult a physician
  • Inactive ingredients

    aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water.

  • Package/Label Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    TOPCARE PAIN RELIEF PATCH 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-007-055 in 1 CARTON01/01/2022
    11 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2022
    Labeler - Topco Associates LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd529128763manufacture(76162-007)