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

  • NDC Code(s): 81484-901-01, 81484-901-02, 81484-901-03, 81484-901-04
  • Packager: Anhui Miao De Tang Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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

  • SPL UNCLASSIFIED SECTION

    Lidocaine Patch

  • ACTIVE INGREDIENT

    Lidocaine 4%,Menthol 1%

  • PURPOSE

    For the temporary relief of palin

  • INDICATIONS & USAGE

    For the temporary relief of palin, TOPICAL ANESTHETIC

  • WARNINGS

    For external use only

  • DO NOT USE

    more than 1 patch on your body at a time or on cut, irritated or swollen skin

  • WHEN USING

    use only as directod. Read and follow all directions and warnings on this label.
    rare cases of serious bums have been reported with products of this type
    do not apply to wounds or damaged, broken or irritated skin
    do not allow contact with the eyes and mucous membranes
    do not bandage tightly or apply local heat (such as heating pads) to the area of use
    do not use at the same time as other topical analgesics

  • STOP USE

    condition worsens
    rodness is present
    irritation develops
    symptoms persist for more than 7 days or clear up and occur again within a few days
    you experience sians ot skin injury, such as pain, swelling, or blistering where the product was applied

  • KEEP OUT OF REACH OF CHILDREN

    it swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age and over:
    clean and dry aftecied area
    remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
    carefully remave smaller portion of backing from patch and apply exposed portion of patch to atlected area
    once exposed portion of patch is positioned, carefully remove remaining backing to completely applypatch to aitected area
    use 2 patch tor up to 24 hours
    Children under 12 years of age:consult a doctor

  • STORAGE AND HANDLING

    Store in a clean, dry place outside of direct sunlight. Protect product from excessive moisture.

  • INACTIVE INGREDIENT

    Aluminum Glycinate
    Aluminum Hydroxide
    Cellulose Gum
    Glycerin
    Methylparaben
    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

    label

    label2

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PATCH 
    lidocaine 4%, menthol 1% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81484-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.01 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.04 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    UREA (UNII: 8W8T17847W)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81484-901-032 in 1 PACKAGE09/14/2023
    1NDC:81484-901-026 in 1 BOX
    1NDC:81484-901-011 in 1 BAG; Type 0: Not a Combination Product
    2NDC:81484-901-0430 in 1 BOX11/14/2023
    2NDC:81484-901-011 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/14/2023
    Labeler - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anhui Miao De Tang Pharmaceutical Co., Ltd.405744102manufacture(81484-901)