Label: LIDOZEN- lidocaine hydrochloride, menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 21, 2021

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

  • 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 not finalpart34805/01/2019
    Labeler - Village Pharma LLC (080749749)