Label: LIDOPRO PATCH (LIDOCAINE 4%, MENTHOL 1%)- lidocaine and menthol patch patch

  • NDC Code(s): 83881-402-05, 83881-402-15
  • Packager: Clinic Pharma
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2025

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  • Active ingredient

    Lidocaine 4%

    Menthol 1%

  • Purpose

    External Anesthetic

    External Analgesic

  • Uses

    For the temporary relief of pain.

  • Warnings

    For external use only.

    Do not use

    • on the face or rashes, on wounds or damaged skin
    • in the eyes, mouth, or other mucous membranes
    • on genitals
    • with a heating pad
    • right before or after heart surgery
    • any patch from a pouch that has been opened for 7 or more days
    • in large quantities, particularly over raw surfaces or blistered areas
    • if tamper-evident seal is torn, broken, or missing
    • more than 2 patches per day unless directed by a doctor
    • children under 18 years of age

    Ask a doctor before use if you have

    • allergies to topical products
    • high blood pressure, heart disease, or kidney disease

    When using this product

    • Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
    • The risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

    Stop use and ask doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    If pregnant of breast-feeding, ask a health professional before use

    Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

    If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose if the used patches by folding sticky ends together.

  • Directions

    Adults 18 years and older:

    • clean and dry affected area
    • open pouch and remove one patch
    • remove protective film from patch
    • apply one patch to the affected area of pain and leave in place for 8 to 12 hours
  • Other information

    • Some individuals may not experience pain relief until several minutes or hours after applying the patch
    • avoid storing product in direct sunlight
    • protect product from excessive moisture
    • store at 67-77ºF (19-25ºC)
  • Inactive ingredients

    Carboxymethylcellose sodium, Dihydroxyaluminum aminoacetate, Edetate sodium, Glycerin, Kaolin, Methyl parahydroxybenzoate, Partially neutralized Sodium polyacrylate, Polyacrylic acid, Polysorbate 80, Propyl parahydroxybenzoate, Propylene glycol, Sodium Polyacrylate, Tartaric acid, Titanium dioxide, water

  • Questions?

    Call toll-free (800) 224-2048

  • 402-15

    402-15

    402-05

  • INGREDIENTS AND APPEARANCE
    LIDOPRO PATCH (LIDOCAINE 4%, MENTHOL 1%) 
    lidocaine and menthol patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83881-402
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL84 mg  in 8400 mg
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE336 mg  in 8400 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    KAOLIN (UNII: 24H4NWX5CO)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83881-402-055 mg in 1 POUCH; Type 0: Not a Combination Product01/09/2025
    2NDC:83881-402-1515 mg in 1 POUCH; Type 0: Not a Combination Product01/09/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/09/2025
    Labeler - Clinic Pharma (119158469)
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