Label: TOPCARE PAIN RELIEF PATCH- lidocaine, menthol patch

  • 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 January 12, 2022

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 not finalpart34801/01/2022
    Labeler - Topco Associates LLC (006935977)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd529128763manufacture(76162-007)