SINSINPAS LIDOCAINE PAIN RELIEVING (LIDOCAINE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]

SINSINPAS LIDOCAINE PAIN RELIEVING (LIDOCAINE) PATCH [SINSIN PHARMACEUTICAL CO., LTD.]
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NDC 55264-106-01, 55264-106-02, 55264-106-03
Set ID 82c0a036-8750-5b3d-e053-2a91aa0a1815
Category HUMAN OTC DRUG LABEL
Packager Sinsin Pharmaceutical Co., Ltd.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • Active Ingredients

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Keep out of reach of children or pets

    Keep out of reach of children or pets.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)

  • Uses

    For the temporarily relief of minor pain

  • Warnings

    For external use only



    Do not use

    • more than 1 patch at a time
    • on broken, irritated, or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • use only as directed. Read and follow all direction and warning on this label
    • Avoid contact with the eyes or mucous membranes
    • Do not apply to broken, damaged, or irritated skin
    • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • Rare cases of serious burns have been reported with products of this type
    • Do not use with other topical analgesics
    • Keep children and pets away from used or disposed patch.
    • Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this product.
  • Directions

    Adults and children 12 years of age and over:

    • clean and dry affected area
    • remove film from patch by gently pulling apart from corner
    • carefully apply to afftcted area
    • once patch is positioned, press firmly to adhere to skin
    • use only one patch at a time for up the 12 hours

    Children under 12 years of age: consult a professional

  • Inactive Ingredients

    butylated hydroxytoluene
    carboxymethylcellulose sodium
    glycerin
    edetate disodium
    isopropyl myristate
    kaolin
    magnesium aluminosilicate
    methyl acrylate and 2-ethylhexyl acrylate copolymer aqueous emulsion (mixture)
    methyl paraben
    polyacrylic acid
    polysorbate 80
    propylene glycol
    propyl paraben
    purified water
    sodium polyacrylate
    sorbitan sesquioleate
    tartaric acid
    urea

  • SINSINPAS LIDOCAINE PAIN RELIEVING PATCH

    02-25-2019

  • INGREDIENTS AND APPEARANCE
    SINSINPAS LIDOCAINE PAIN RELIEVING 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-106
    Route of AdministrationTOPICAL, CUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE560 mg  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 280 mg  in 14 g
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCERIN (UNII: PDC6A3C0OX) 3500 mg  in 14 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-106-035 in 1 BOX05/25/2017
    1NDC:55264-106-021 in 1 POUCH
    1NDC:55264-106-0114 g in 1 PATCH; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/25/2017
    Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-106)

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