Label: ASPERCREME- lidocaine patch

  • NDC Code(s): 62168-0584-1, 62168-0584-2, 62168-0584-3, 62168-0584-4
  • 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 September 16, 2021

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

  • Active ingredient – Lidocaine Patch US 1ct

    Lidocaine 4%

  • Purpose – Lidocaine Patch US 1ct

    Topical anesthetic

  • Use – Lidocaine Patch US 1ct

    for the temporary relief of pain

  • Warnings – Lidocaine Patch US 1ct

    For external use only

  • Do not use – Lidocaine Patch US 1ct

    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 – Lidocaine Patch US 1ct

    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 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 – Lidocaine Patch US 1ct

    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, – Lidocaine Patch US 1ct

    ask a health professional before use.

  • Keep out of reach of children and pets. – Lidocaine Patch US 1ct

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions – Lidocaine Patch US 1ct

    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 under 12 years or age: consult a doctor

  • Inactive ingredients – Lidocaine Patch US 1ct

    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

  • Active ingredient – Lidocaine Patch Singles US 1ct

    Lidocaine 4%

  • Purpose – Lidocaine Patch Singles US 1ct

    Topical Anesthetic

  • Use – Lidocaine Patch Singles US 1ct

    temporarily relieves minor pain

  • Warnings – Lidocaine Patch Singles US 1ct

    For external use only

  • Do not use – Lidocaine Patch Singles US 1ct

    more than 1 patch on your body at a time or on cut, irritated or swollen skin
    on puncture wounds
    for more than one week without consulting a doctor
  • When using this product – Lidocaine Patch Singles US 1ct

    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 – Lidocaine Patch Singles US 1ct

    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, – Lidocaine Patch Singles US 1ct

    ask a health professional before use.

  • Keep out of reach of children and pets. – Lidocaine Patch Singles US 1ct

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions – Lidocaine Patch Singles US 1ct

    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 for up to 12 hours

    children 12 years or younger: ask a doctor

  • Inactive ingredients – Lidocaine Patch Singles US 1ct

    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 – Lidocaine Patch US 1ct

    MAX STRENGTH

    Aspercreme®
    with 4% LIDOCAINE
    PAIN RELIEF PATCH

    NUMBS AWAY PAIN
    FAST ACTING
    TARGETS NERVES
    FLEXIBLE FABRIC

    #1 LIDOCAINE BRAND*

    PATCH

    FRAGRANCE-FREE
    Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)
    Pain Relieving Ointment on a Breathable Adhesive Pad

    *Among OTC topical analgesics.


    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

  • Package/Label Principal Display Panel – Lidocaine Patch Singles US 1ct

    MAX STRENGTH LIDOCAINE
    NOW WITH
    BETTER ADHESION*

    ODOR FREE
    Aspercreme®
    LIDOCAINE PATCH

    THE NUMBER ONE ODOR FREE BRAND

    NUMBS
    AWAY PAIN

    Powerful
    Pain Relief
    Fast Acting
    Non Irritating

    *Compared to previous formulation of the Aspercreme® with Lidocaine Patch.
    Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)
    Pain Relieving Ointment on a Breathable Adhesive Pad

    4% Lidocaine


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

    image-02

    Label

  • INGREDIENTS AND APPEARANCE
    ASPERCREME 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0584
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE246 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:62168-0584-11 in 1 POUCH; Type 0: Not a Combination Product08/01/201607/31/2022
    2NDC:62168-0584-2400 in 1 CARTON05/10/201607/31/2022
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:62168-0584-3400 in 1 CARTON11/06/202004/30/2023
    31 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:62168-0584-4400 in 1 CARTON05/17/2021
    41 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/16/2016
    Labeler - Lead Chemical Co. Ltd. (693727091)
    Registrant - Lead Chemical Co. Ltd. (693727091)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lead Chemical Co. Ltd.718216992ANALYSIS(62168-0584) , MANUFACTURE(62168-0584)