Label: ALIVIO- lidocaine patch

  • NDC Code(s): 82598-101-01, 82598-101-03, 82598-101-20
  • Packager: Amerise Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 27, 2024

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

  • Active Ingredients

    Lidocaine 4% .................................... Topical Anesthetic

  • Use

    Temporarily relieves minor pain

  • PURPOSE

    Temporarily relieves minor pain

  • Warnings

    For external use only.

    Do not use

    • 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

    • use only as directed. Read and follow all directions and warning on this carton
    • rare cases of serious burns have been reported with products of this type
    • do not apply to wonds or damaged, broken or irritated skin
    • do not allow contact with the eyes and mucous membranes
    • 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 keep 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
    • a transient buring sensation may occur upon applicaiton but generally disappears in several day
    • if a severe buring sensation occurs, discontinue use immediately

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • sypmtoms 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, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 back separates in middle
    • use 1 patch for up to 12 hours

    Children 12 years or younger; ask a doctor

  • Inactive Ingredients

    alpha-tocopherol acetate, aluminum hydroxide, aluminum silicate, butylated hydroxytoluene, butyl rubber, isoprene rubber, mineral oil, polyisobutylene, rosin, silicon dioxide, styrene/isoprene/styrene block, titanium dioxide

  • SPL UNCLASSIFIED SECTION

    Distributed in US by:

    Amerise Pharmaceuticals LLC

    6 Corporate Dr, Cranbury, NJ 08512

    Customer Care NO.: 609-721-9587

    Email: help@amerisepharma.com

  • PRINCIPAL DISPLAY PANEL

    Carton Image

    Pouch Image

  • PRINCIPAL DISPLAY PANEL

    Lidocaine Carton - 3 pack

  • INGREDIENTS AND APPEARANCE
    ALIVIO 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82598-101
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
    Inactive Ingredients
    Ingredient NameStrength
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ROSIN (UNII: 88S87KL877)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISOPRENE (UNII: 0A62964IBU)  
    ISOBUTYLENE (UNII: QA2LMR467H)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82598-101-2020 in 1 CARTON06/17/2022
    1NDC:82598-101-011 in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:82598-101-033 in 1 CARTON; Type 0: Not a Combination Product06/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/16/2022
    Labeler - Amerise Pharmaceuticals LLC (089951382)