Label: WELMATE LIDOCAINE PAIN RELIEVING PATCH- lidocaine patch

  • NDC Code(s): 73581-911-15, 73581-911-30
  • Packager: Yyba Corporation
  • 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 September 15, 2022

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  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Uses

    For temporary relieves minor pain

  • Warnings

    For external use only

    Do not use

    • more than one patch on your body at a time
    • On cut, irritated 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 directions and warnings on this carton
    • do not allow contact with 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 used patch in manner that always keeps 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.

    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 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 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 backing from patch starting at a corner.
    • Apply sticky side of patch to 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, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

  • Questions or comments?

    Toll free 866-933-6337 www.salonpas.us

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    WELMATE LIDOCAINE PAIN RELIEVING PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-911
    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
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    KAOLIN (UNII: 24H4NWX5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-911-3030 in 1 CARTON11/01/2021
    111 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:73581-911-1515 in 1 CARTON09/01/2022
    211 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 finalpart34811/01/2021
    Labeler - Yyba Corporation (006339772)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(73581-911)
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