Label: SINSINPAS LIDOCAINE PAIN RELIEVING- lidocaine patch

  • NDC Code(s): 55264-106-01, 55264-106-02, 55264-106-03
  • Packager: Sinsin Pharmaceutical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 12, 2024

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

  • Active ingredient

    Lidocaine 4%

    Purpose.... Topical anesthetic

  • Uses

    For temporary 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 directions and warnings 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.

  • Stop use and ask a doctor if

    condition worsens

    irritation develops

    redness is present

    symptoms persist for more than 7 days or clear up and occur again within a few days

    any signs of skin injury appear at the site of the product application such as pain, swelling, bruising, or blistering

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a physician before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children or pets. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Other information

    avoid storing in direct sunlight

    protect product from excess moisture

    store at room temperature.

    Do not exceed 86° Fahrenheit, 30° Celsius

  • Directions

    Adults/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 affected area

    once patch is positioned, press firmly to adhere to skin

    use only one patch at a time for up to 12 hours

  • Ask a doctor

    Children under 12 years of age: consult a healthcare professional

  • Inactive ingredients

    butylated hydroxytoluene, carboxymethylcellulose sodium, Concentrated Glycerin, Disodium edetate Hydrate

    isopropyl myristate, kaolin, magnesium aluminosilicate, Nikazole TS-620,

    methyl paraben, polyacrylic acid solution, polysorbate 80, propylene glycol, propyl paraben, purified water,

    sodium polyacrylate, sorbitan sesquioleate, tartaric acid, titanium dioxide, urea, D-sorbitol solution,

  • Purpose

    Topical anesthetic

  • Uses

    For temporary relief of minor pain

  • 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

  • PRINCIPAL DISPLAY PANEL

    SINSINPAS

    MAXIMUM STRENGTH

    LIDOCAINE 4% PAIN RELIEVING PATCH

    TARGETS PAIN FOR QUICK RELIEF

    PERETRATES NERVE RECEPTORS TO NUMB AND DESENSITIZE

    LONG LASTING AND UNSCENTED

    EASY TO APPLY

    5 PATCHES

    3.93 IN X 5.51 IN, EACH

    ODOR FREE

    SINSINPAS LIDOCAINE PAIN RELIEF PATCH

  • INGREDIENTS AND APPEARANCE
    SINSINPAS LIDOCAINE PAIN RELIEVING 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-106
    Route of AdministrationTRANSDERMAL
    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)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeRECTANGLESize14mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55264-106-035 in 1 BOX05/25/201702/04/2022
    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 DrugM01705/25/201712/30/2049
    Labeler - Sinsin Pharmaceutical Co., Ltd (823149161)
    Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)