Label: LIDO KING- 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 April 13, 2020

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  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Uses

    For temporary relief of pain

  • Warnings

    For external use only

    Do not use

    •
    if you are allergic to any ingredients of this product
    •
    more than one patch at a time
    •
    on wounds or damaged skin
    •
    with a heating pad
    •
    if pouch is damaged or opened

    When using this product

    •
    avoid contact with the eyes, mucous membranes or rashes
    •
    use only as directed
    •
    do not bandage tightly
    •
    do not reuse patch

    Stop use and ask a doctor if

    •
    localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    •
    symptoms clear up and occur again within a few days
    •
    symptoms persist for more than 7 days
    •
    conditions worsen

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and over:

    •
    cut to desired size, if necessary
    •
    clean and dry affected area
    •
    remove film from patch and apply to the skin (see illustration)
    •
    apply to affected area not more than 3 to 4 times daily
    •
    remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

  • Other information

    •
    store at 68°-77°F (20°-25°C)
    •
    protect product from freezing, excessive heat and moisture
    •
    avoid storing product in direct sunlight
  • Inactive ingredients

    dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methylparaben, polyacrylic acid, polyvinyl alcohol solution, propylene glycol, propylparaben, purified water, sodium carboxymethylcellulose, sodium polyacrylate, sodium polyacrylate starch, sorbitol solution, tartaric acid, urea

  • Questions or comments?

    Toll free 1-833-525-0303  www.lidokingpatch.com

    For Galaxy Bio, Inc.

    Monmouth Junction, NJ 08852

    Made in Taiwan

    *Available without a prescription

    ® Registered Trademark

  • PRINCIPAL DISPLAY PANEL

    NEW

    APPLY FOR

    8

    HOURS

    LIDO KING ®

    LIDOCAINE 4%

    Pain Relieving Gel-Patch

    Maximum Strength*

    Numbing Relief

    Good Skin Feel

    Unscented

    For temporary relief of pain

    •
    Back
    •
    Neck
    •
    Shoulders
    •
    Knees
    •
    Elbows
    •
    Legs
    •
    Arms

    5 PATCHES

    3 15/16" x 5 1/2" (10 cm x 14 cm)

    NDC: 73354-1279-2

    Lido King (Lidocaine 4%) label
  • INGREDIENTS AND APPEARANCE
    LIDO KING 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73354-1279
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITOL (UNII: 506T60A25R)  
    TARTARIC ACID (UNII: W4888I119H)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73354-1279-25 in 1 CARTON12/01/2019
    11 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2019
    Labeler - Galaxy Bio, Inc. (782793231)
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