Label: LIDOCAINE PAIN RELIEF patch

  • NDC Code(s): 0121-0970-01, 0121-0970-05
  • Packager: PAI Holdings, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • Active ingredient(s)

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Uses

    Temporary relief of pain

  • Warnings

    For external use only

    Do not use

    • more than one patch at a time
    • on wounds or damaged, broken or irritated skin
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed          • read and follow all directions and warnings
    • do not allow contact with eyes and mucous membranes
    • do not bandage tightly      • do not apply local heat such as a heating pad
    • do not use other topical anesthetics at the same time

    Stop use and ask a doctor if

    • localized skin reactions occur, such as rash, itching, redness, irritation,
      pain, swelling and blistering
    • conditions 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 healthcare professional before use.

    Keep out of reach of children

    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 film from patch and apply to the skin
    • apply one patch to affected area not more than 3 to 4 times a day
    • remove patch from the skin after at most 12-hour application

    Children under 12 years of age: consult a doctor

  • Inactive ingredients

    dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl
    alcohol, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, D-sorbitol, tartaric acid, urea, water

  • Comments or Questions:

    1-800-845-8210

    ††This product is not manufactured or distributed by Chattem, Inc., distributor of Aspercreme® Lidocaine Patch.

  • Distributed by

    PAI LOGO

     MADE IN JAPAN

    C09750050222 R02/22

  • Principal Display Panel

    lidocaine-patch

    lidocaine patch


  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PAIN RELIEF 
    lidocaine pain relief patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0970
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE560 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITOL (UNII: 506T60A25R)  
    TARTARIC ACID (UNII: W4888I119H)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0121-0970-0512 in 1 CASE04/03/2023
    15 in 1 CARTON
    1NDC:0121-0970-011 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)04/03/2023
    Labeler - PAI Holdings, LLC (044940096)
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