Label: PAIN RELIEVING LIDOCAINE PATCH- lidocaine patch

  • NDC Code(s): 71811-003-30, 71811-003-40
  • Packager: InterMed Laboratories Private Limited
  • 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 July 28, 2023

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

  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Uses

    Temporarily relieves minor pain

  • Warnings

    For external use only

  • Do Not Use

    • more than 1 patch on your body at a time or on cut, irritated or swollen skin
    • on puncture wounds or damaged skin
    • with a heating pad
    • if you are allergic to ingredients of this product
  • When Using This Product

    • use only as directed. Read and follow all directions and warnings on this label.
    • do not allow contact with the eyes
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • do not use at the same time as other topical analgesics
    • dispose of used patch in manner that always keeps product away from children or 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
    • symptoms clear up and occur again within few days
  • 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 right away.

  • Directions

    Adults and children over 12 years:

    • clean and dry affected area
    • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
    • carefully remove from the skin after at most 8-hour application
    • apply to the affected area not more than 3 to 4 times daily

    children 12 years or younger:ask a doctor

  • Inactive Ingredients

    dihydroxyaluminium aminoacetate, disodium EDTA, glycerin, methylparaben, polyvinyl alcohol, propyl paraben, propylene glycol, purified water, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric acid, titanium oxide

  • Package/Label Principal Display Panel

    1V

    40

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING LIDOCAINE PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71811-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71811-003-3030 in 1 CARTON09/17/2020
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:71811-003-4040 in 1 CARTON09/17/2020
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/17/2020
    Labeler - InterMed Laboratories Private Limited (676244169)