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
  • 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 August 3, 2023

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 not finalpart34811/08/2022
    Labeler - Neptune Products (081502369)