Label: LIDOREAL PATCH- lidocaine and menthol patch

  • NDC Code(s): 81877-725-15
  • Packager: FORREAL PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 17, 2024

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  • Drug Facts

  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Active Ingredient

    Menthol 1%

  • Purpose

    Topical 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 consult a 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 or 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 of 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
    • if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
    • only use one patch at a time
    • wash hands with soap and water after applying or removing patch
    • reseal pouch containing unused patches after each use
  • 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 67-77°F (19-25°C)
  • Inactive Ingredients

    dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polusorbate 80, polyvinyl pyrrolidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • Questions?

    877-367-3250

  • Principal Display Panel

    NDC 81877-725-15

    Forreal Pharmaceuticals
    YOUR SOLUTION TO BETTER HEALTHCARE.

    LIDOREAL

    Lidocaine 4% and Menthol 1% Patch

    15 PATCHES

    10 cm x 14 cm each

    LidoPro Patch

  • INGREDIENTS AND APPEARANCE
    LIDOREAL PATCH  
    lidocaine and menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-725
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    KAOLIN (UNII: 24H4NWX5CO)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81877-725-1515 in 1 BOX; Type 0: Not a Combination Product05/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/15/2024
    Labeler - FORREAL PHARMACEUTICALS LLC (118029197)
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