Label: LIDOCAINE patch

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 16, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • 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

    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, 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, you are taking a diuretic, you have high blood pressure, heart disease, kidney disease, or 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.

    Stop use and consult your physician if rash, irritation, or itching develops, or condition worsens.

    If pregnant or breastfeeding, ask a doctor before use while breastfeeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Adults and children 12 years and over: apply 1 to 2 patches to the affected area of intact skin. Lidocaine patch should be removed after 12 hours of continuous use and remain off for at least 12 hours.

  • SPL UNCLASSIFIED SECTION

    INSTRUCTIONS FOR USE

    • Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors 
    • Safely discard the remaining unused pieces of cut patches where children and pets cannot reach 
    • Remove the transparent protective film (clear plastic barrier) before application of patches to the skin 
    • Apply immediately after removing the protective film Apply 1 patch to the affected area so that the patch covers all or most of the painful area
    • Remove patch if irritation occurs

    Children under 12 years of age: Consult a doctor.

  • Inactive ingredients

    dihydroxyaluminum aminoacetate, edetate disodium, glycerin, isopropyl myristate, polyacrylic acid, propyl p-hydroxybenzoate, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

  • 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 the product from excessive moisture or sunlight. Store at 67-77°F (19-25°C).

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79643-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79643-005-0110 in 1 BOX11/29/2024
    114 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/29/2024
    Labeler - PHARMACURE LLC (055983858)