Label: LIDOZEN- lidocaine hydrochloride, menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • DRUG FACTS:

  • ACTIVE INGREDIENTS:

    Lidocaine HCL 4.00%

    Menthol 1.00%

    Toplcal Anesthetic

    External Analgesic

  • USES:

    For temporary relief of pain

  • WARNINGS:

    • For external use only.
    • Avoid contact with eyes.
    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

    Do not use 

    in large quantities, particularly over raw surfaces or blistered areas.

    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 Over 12 Years):

    Clean and dry affected area.

    Remove patch from backing and apply to affected area.

    Use only one patch at a time, and maximum of four patches / day.

    Leave patch on affected area for up to 8 hours.

    Do not use patches for longer than five consective days.

    Children under 12 should consult physician prior to use.

  • INACTIVE INGREDIENTS:

    Propylene Glycol, Carboxymethyl Cellulose Sodium, Dihydroxyaluminum Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Polysorbate 80, Polyvinylpyrrolidone 90, Tartaric Acid, Tetrasodium Edetate, Titanium Dioxide, Hydrogenated Castor Oil, Phenoxyethanol, Urea, Water.

  • SPL UNCLASSIFIED SECTION

    Store below 25 degrees Celsius. Avoid directed sunlight.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    LIDOZEN 
    lidocaine hydrochloride, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TARTARIC ACID (UNII: W4888I119H)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71574-800-055 in 1 POUCH05/01/2019
    11 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/01/2019
    Labeler - Village Pharma LLC (080749749)
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