SALONPAS LIDOCAINE PAIN RELIEVING (LIDOCAINE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]

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  • SALONPAS LIDOCAINE PAIN RELIEVING (LIDOCAINE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]

SALONPAS LIDOCAINE PAIN RELIEVING (LIDOCAINE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]
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NDC 46581-830-02, 46581-830-06, 46581-830-15
Set ID 4f3a438c-f378-4d2a-a95c-58e56cf1e797
Category HUMAN OTC DRUG LABEL
Packager Hisamitsu Pharmaceutical Co., Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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 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

    OTC topical analgesics in patch category*
    WORLD'S BRAND NO.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*1

    • Numbing Relief
    • Unscented

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

    MADE IN JAPAN

    image of 6-patch box label

  • Principal Display Panel

    CUT OPEN HERE

    NDC#46581-830-01

    HOW TO APPLY
    1 Pull apart.
    2 Peel off one side of the film.
    3 Place on affected area.
    4 Peel off the remaining film.
    5 Press patch thoroughly.

    Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

    APPLY FOR 8 HOURS

    MAXIMUM STRENGTH*1

    • Numbing Relief
    • Unscented

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

    Child-resistant packaging.

    Hisamitsu

    MADE IN JAPAN

    image of 1-patch pouch 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
    4NDC:46581-830-011 in 1 POUCH; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2016
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)
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