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

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 November 22, 2022

If you are a healthcare professional or from the pharmaceutical industry 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 not finalpart34806/16/2022
    Labeler - Amerise Pharmaceuticals LLC (089951382)