Label: HEALTHWISE LIDOCAINE PAIN RELIEF- lidocaine patch

  • 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 October 12, 2021

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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)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    KAOLIN (UNII: 24H4NWX5CO)  
    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 not finalpart34810/01/2016
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(71101-915)
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