Label: MENCAINE- lidocaine, menthol patch

  • NDC Code(s): 72594-1090-1, 72594-1090-5
  • Packager: Neptune Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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

  • ACTIVE INGREDIENT

    Active Ingredients (in each patch):

    Lidocaine 4.5% Topical Anesthetic

    Menthol 5% Topical Analgesic

  • PURPOSE

    USES:

    Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

    • Muscle soreness
    • Strains
    • Sprains
    • Arthritis
    • Simple backache
    • Muscle stiffness
    • Bruises
  • WARNINGS

    WARNINGS:

    For external use only

    This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you:

    • Are age 60 or older
    • Have had stomach ulcers or bleeding problems
    • Take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)
    • Take a blood thinning (anticoagulant) or steroidal drug
    • Have three or more alcoholic drinks every day while using this product
    • Take more or for a longer time than directed

    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
    • If allergic to any NSAID’s
    • Right before or after heart surgery
    • Any patch from a pouch that has been opened for 7 or more days

    Ask a doctor before use if:

    • You are allergic to topical products
    • The stomach bleeding warning applies to you
    • You are takin a diuretic
    • You have high blood pressure, heart disease, or kidney disease
    • You are pregnant

    When using this product:

    • Wash hands after applying or removing patch
    • 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 your physician if:

    • Stomach pain or upset gets worse or lasts
    • Rash, irritation, or itching develops
    • You feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)
    • Condition worsens

    If pregnant or breast feeding, ask a doctor before use while breast feeding and during the first 6 months of pregnancy. 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

    Keep out of reach of children, if put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.

  • DOSAGE & ADMINISTRATION

    Adults, or children over the age of 12:

    Apply patch to affected are 1 to 2 times daily or as directed

    Children under 12 years of age:

    Do not use

  • INDICATIONS & USAGE

    INSTRUCTIONS FOR USE:

    • 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
    • Do not use more than 2 patches per day
    • Wash hands with soup and water after applying or removing patch
    • Reseal pouch containing unused patches immediately after each use
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION:

    • Some individuals may not experience pain relief until several minutes or hours after applying the patch
    • Store in a cool, dry place
    • Protect product from excessive moisture or sunlight
    • Store at 67-77o F (19-25o C)
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerine, Kaolin, Partially Neutralized Polyacrylate, Phenoxyethanol, Polysorbate 80, Polyvinyl Pyrrolidone, Tartaric Acid, Tetrasodium EDTA, Water

  • PRINCIPAL DISPLAY PANEL

    mencaine

    box 1090-5

  • INGREDIENTS AND APPEARANCE
    MENCAINE 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72594-1090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4.5 mg  in 100 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY)  
    .ALPHA.-ISOBUTYLPHENETHYL ALCOHOL (UNII: 2SBL0E1I0N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72594-1090-11 mg in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug11/08/2022
    2NDC:72594-1090-55 in 1 BOX11/08/2022
    23 in 1 POUCH
    28500 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/08/2022
    Labeler - Neptune Products (081502369)