Label: ASPERCREME- lidocaine patch

  • NDC Code(s): 62168-0584-4, 62168-0584-5, 62168-0584-6
  • Packager: Lead Chemical Co. Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 25, 2024

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  • 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 wounds or on irritated or damage skin
    •
    more than 1 patch on your body at a time or with other topical analgesics at the same time
    •
    with a heating pad

    When using this product – Lidocaine Patch US 1ct

    •
    use only as directed
    •
    do not bandage tightly
    •
    avoid contact with the eyes and mucous membranes
    •
    do not expose the area to local heat or to direct sunlight

    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 is present or excessive skin irritation occurs
    •
    you experience severe burning 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

    Used patches may still contain the drug product that can produce serious adverse effects if ingested by children or pets. 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
    •
    apply to the affected area not more than 3 to 4 times daily
    •
    wash hands after applying or removing patch. Throw away the patch after folding sticky ends together.

    •   children under 12 years of age: ask 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

    For the temporarily relief of pain

  • Warnings – Lidocaine Patch Singles US 1ct

    For external use only

    Do not use – Lidocaine Patch Singles 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 Singles 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 Singles 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 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 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 of age: consult 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 PAINFAST 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.


    Dist. by Chattem, Inc., a Sanofi Company
    P.O. Box 2219, Chattanooga, TN
    37409-0219 USA
    ©2022
    www.aspercreme.com     Made in Japan

    image-01

    Label

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

    MAX STRENGTH

    Aspercreme®with 4% LIDOCAINE
    PAIN RELIEF PATCH

    NUMBS AWAY PAINFAST 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-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:62168-0584-4400 in 1 CARTON05/17/202103/31/2025
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:62168-0584-5400 in 1 CARTON02/02/2022
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:62168-0584-6400 in 1 CARTON07/15/2023
    31 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)02/16/2016
    Labeler - Lead Chemical Co. Ltd. (693727091)
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