Label: LIDOZEN- lidocaine, menthol patch

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

Drug Label Information

Updated December 1, 2023

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  • DRUG FACTS:

  • ACTIVE INGREDIENTS:

    Lidocaine 4.00%

    Menthol 1.00%

    Topical 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 consecutive days,

    Children under 12 should consult physician prior to use.

  • INACTIVE INGREDIENTS:

    Water, Glycerol, Sodium Polyacrylate, Propylene Glycol, Polysorbate 80, Tartaric Acid, Dihydroxyaluminium Aminoacetate, Methylparaben

  • SPL UNCLASSIFIED SECTION

    Store below 25 degrees Celsius, Avoid direct sunlight.

  • Package Labeling:

    71205-348-30
  • INGREDIENTS AND APPEARANCE
    LIDOZEN 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-348(NDC:71574-900)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TARTARIC ACID (UNII: W4888I119H)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-348-055 in 1 BOX08/24/2021
    11 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:71205-348-1515 in 1 BOX08/24/2021
    21 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:71205-348-3030 in 1 BOX11/01/2019
    31 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 DrugM01709/16/2019
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-348) , RELABEL(71205-348)
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