Label: ASPERCREME WITH LIDOCAINE XL- lidocaine patch

  • NDC Code(s): 41167-0585-0, 41167-0585-1
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 25, 2023

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  • SPL UNCLASSIFIED SECTION

    Aspercreme LIDOCAINE PATCH XL

    Drug Facts

  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Uses

     for the temporary relief of pain

  • Warnings

    For external use only

    Do not use

    • on puncture wounds, cuts, irritated or swollen skin
    • more than 1 patch on your body at a time or with other topical analgesics at the same time
    • with a heating pad or apply local heat to the area of use

    When using this product

    • use only as directed
    • do not bandage tightly
    • avoid contact with the eyes
    • 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 or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • redness or irritation develops
    • 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 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 smaller portion of backing from patch and apply exposed portion of patch to affected area
    • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
    • use 1 patch at a time and not more than 3 to 4 times daily

    children 12 years or younger: consult a doctor

  • Inactive ingredients

    aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water

  • PRINCIPAL DISPLAY PANEL

    Aspercreme
    Lidocaine Patch XL

    Aspercreme Lidocaine Patch XL

  • INGREDIENTS AND APPEARANCE
    ASPERCREME WITH LIDOCAINE  XL
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0585
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE422 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYGALIC ACID (UNII: XCC6WEA55L)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0585-14 in 1 CARTON10/21/201710/22/2017
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:41167-0585-03 in 1 CARTON10/21/2017
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/21/2017
    Labeler - Chattem, Inc. (003336013)
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