Label: SALONPAS LIDOCAINE PAIN RELIEVING- lidocaine patch

  • NDC Code(s): 46581-830-02, 46581-830-06, 46581-830-15
  • Packager: Hisamitsu Pharmaceutical Co., Inc.
  • 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 June 15, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical anesthetic

  • Uses

    For temporary relief of pain

  • Warnings

    For external use only

    Do not use

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

    When using this product

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

    Stop use and ask a doctor if

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

    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:

    • clean and dry affected area
    • remove film from patch and apply to the skin (see illustration)
    • apply to affected are 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

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
  • Inactive ingredients

    aluminum silicate, dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, methylparaben, oleic acid, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • Questions or comments?

    Toll free 1-800-826-8861   www.salonpas.us

  • Principal Display Panel

    IMPROVED ADHESION*1

    Hisamitsu

    NDC#46581-830-06

    Desensitize aggravated nerves
    for temporary relief of pain

    Back
    Neck
    Shoulders
    Knees and Elbows

    Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

    APPLY FOR 8 HOURS

    MAXIMUM STRENGTH*2

    Numbing Relief
    Unscented

    6 PATCHES
    3 15/16" X 5 1/2" (10cm X 14cm)

    MADE IN JAPAN

    image of 6-patch box label

  • INGREDIENTS AND APPEARANCE
    SALONPAS LIDOCAINE PAIN RELIEVING 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-830
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE560 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    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:46581-830-066 in 1 BOX08/01/2016
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:46581-830-022 in 1 BOX10/01/2017
    21 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:46581-830-1515 in 1 BOX08/01/2017
    31 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2016
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)