Label: LIDOCAINE PATCH- lidocaine 4%, menthol 1% patch

  • NDC Code(s): 84273-002-01
  • Packager: Hunan En Pu Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2024

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  • SPL UNCLASSIFIED SECTION

    Lidocaine Patch

  • ACTIVE INGREDIENT

    Lidocaine 4%
    Menthol 1%

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints

  • WARNINGS

    For external use only

  • DO NOT USE

    use only as directed
    avoid contact with eyes
    do not apply to wounds or damaged skin
    do not bandage tightly or apply any other heating pads to the affected area

  • WHEN USING

    use only as directed
    avoid contact with eyes
    do not apply to wounds or damaged skin
    do not bandage tightly or apply any other heating pads to the affected area

  • STOP USE

    if condition worsens
    if symptoms clear up and occur again within a few days
    if redness and irritation develop
    if symptoms persist for more than 7 days, consult a doctor

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older
    clean and dry affected area
    remove backing trom patch and firmly grasp both ends, gently pull backing until it separates up to the middle
    slowly apply the patch to the affected area and gently remove any remaining backing from the patch
    apply to affected area not more than 3 to 4 times daily

  • STORAGE AND HANDLING

    Store in a clean, and dry place outside of direct sunlight.

  • INACTIVE INGREDIENT

    Aluminum Glycinate
    Aluminum Hydroxide
    Cellulose Gum
    DMDM hydantoin
    Glycerin
    PEG-40 Hydrogenated Castor Oil
    Polyacrylic Acid
    Polysorbate 80
    Propylene Glycol
    Ricinus Communis Seed Oil (Castor)
    Silica
    Sodium Polyacrylate
    Tartaric Acid
    Titanium Dioxide
    Urea
    Water

  • PRINCIPAL DISPLAY PANEL

    label2

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PATCH 
    lidocaine 4%, menthol 1% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84273-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    TARTARIC ACID (UNII: W4888I119H)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84273-002-016 in 1 BOX04/22/2024
    11 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/22/2024
    Labeler - Hunan En Pu Pharmaceutical Co., Ltd. (842391330)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hunan En Pu Pharmaceutical Co., Ltd.842391330manufacture(84273-002)
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