Label: ASPERCREME LIDOCAINE XL- lidocaine patch

  • NDC Code(s): 62168-0585-1, 62168-0585-2
  • Packager: Lead Chemical Co., Ltd.
  • 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 June 23, 2021

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

  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Use

    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 12 years of age and older:

    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

  • Package/Label Principal Display Panel

    MAX STRENGTH

    Aspercreme®
    with 4% LIDOCAINE
    PAIN RELIEF PATCH

    NUMBS AWAY PAIN
    FAST ACTING
    TARGETS NERVES
    FLEXIBLE FABRIC

    #1 LIDOCAINE BRAND*

    XL PATCH
    71% LARGER

    FRAGRANCE-FREE
    Contains 1 Patch 4-¾” x 7-7/8” (12 cm x 20 cm)
    Pain Relieving Ointment on a Breathable Adhesive Pad

    *Among OTC topical analgesics.
    Than 10 cm x 14 cm Aspercreme® patches.


    CHATTEM®
    A SANOFI COMPANY
    Dist. By Chattem, Inc., a Sanofi Company
    P.O. Box 2219, Chattanooga, TN
    37409-0219 USA
    ©2020
    www.aspercreme.com     Made in Japan

    image-01

    Label

  • INGREDIENTS AND APPEARANCE
    ASPERCREME  LIDOCAINE XL
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0585
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE411.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    NONOXYNOL-30 (UNII: JJX07DG188)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62168-0585-1240 in 1 CARTON10/15/201703/31/2023
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:62168-0585-2240 in 1 CARTON05/28/2021
    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 finalpart34810/15/2017
    Labeler - Lead Chemical Co., Ltd. (693727091)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lead Chemical Co., Ltd.718216992ANALYSIS(62168-0585) , MANUFACTURE(62168-0585)