Label: HEALTHWISE LIDOCAINE PAIN RELIEF- lidocaine patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Uses

    For temporary relief minor pain

  • Warnings

    For external use only

    Do not use

    • more than one patch on your body at a time
    • on cut or swollen skin
    • on puncture wounds
    • For more than one week without consulting a doctor if you are allergic to any active or inactive ingredients
    • if pouch is damaged or opened

    When using this product

    • use only as directed
    • read and follow all directions and warnings on this carton
    • Do not allow contact with the eyes
    • Do not use at the same time as other topical analgesics
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • Do not microwave
    • Dispose of a used patch in a manner that always keeps the 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 ingest this patch.

    Stop use and ask a doctor if

    • conditions worsen
    • 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 an 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 800-222-1222 right away.

  • Directions

    Adults and children 12 years of age and over:

    • clean and dry affected area
    • carefully remove the backing from the patch starting at a corner
    • Apply the sticky side of patch to the affected area.
    • Use one patch for up to 12 hours
    • Discard patch after single use

    Children under 12 years of age: consult a physician.

  • Other information

    • store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
  • Inactive ingredients

    aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • Questions or comments?

    Toll free 866-326-1313

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  • INGREDIENTS AND APPEARANCE
    HEALTHWISE LIDOCAINE PAIN RELIEF 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-915
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    KAOLIN (UNII: 24H4NWX5CO)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-915-066 in 1 BOX10/01/2021
    11 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/01/2016
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(71101-915)
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