Label: SALONPAS PAIN RELIEVING LIDOCAINE 4% FLEX- lidocaine patch

  • NDC Code(s): 46581-840-07
  • Packager: Hisamitsu Pharmaceutical Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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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

    • more than 1 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

    • skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
    • 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
    • peel film from patch and apply to the skin (see illustration)
    • apply 1 patch at a time 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

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

    aluminum silicate, mineral oil, polyisobutylene, propylene glycol, styrene-isoprene-styrene block copolymer, terpene resin

  • Questions or comments?

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

  • Principal Display Panel

    OTC topical analgesics in patch category
    WORLD’S BRAND NO.1
    Hisamitsu
    NDC#46581-840-07
    for temporary relief of pain
    PATCH CONTOURS TO YOUR BODY
    Adheres as you move, bend, twist, or flex
    Salonpas Pain Relieving FLEX Patch LIDOCAINE 4%
    APPLY FOR UP TO 8 HOURS
    MAXIMUM OTC STRENGTH
    • Stretchable
    • Thin Fabric
    • Strong Adhesion
    7 PATCHES
    2 3/4" X 3 15/16" (7cm X 10cm)
    MADE IN JAPAN

    image of 7-patch box label

  • INGREDIENTS AND APPEARANCE
    SALONPAS PAIN RELIEVING LIDOCAINE 4% FLEX 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-840
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE42 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46581-840-077 in 1 BOX03/01/2022
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2022
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)
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