Label: PAIN RELIEF LIDOCAINE- lidocaine patch

  • 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 March 31, 2022

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

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Lidocaine 4%.................................................... Topical anesthetic

  • PURPOSE

    Use
    ■ temporarily relieves minor pain

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use
    ■ more than 1 patch on your body at a time or on cut, irritated or
    swollen skin ■ at the same time as other topical analgesics
    ■ on puncture wounds
    ■ for more than one week without consulting a doctor

  • WHEN USING

    When using this product
    ■ use only as directed. Read and follow all directions and
    warnings on this label. ■ do not allow contact with the eyes
    ■ do not bandage tightly or apply local heat (such as heating
    pads) to the area of use
    ■ discontinue use at least 1 hour before a bath or shower
    ■ do not use immediately after a bath or shower
    ■ dispose of used patch in manner that always keeps product
    away from children or pets. Used patches still contain the drug
    product that can produce serious adverse effects if a child or
    pet chews or ingests this patch.

  • STOP USE

    Stop use and ask a doctor if
    ■ condition worsens ■ redness is present
    ■ symptoms persist for more than 7 days or clear up and occur
    again within a few days ■ irritation develops
    ■ you experience signs of skin injury, such as pain, swelling, or
    blistering where the product was applied

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or
    contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions
    ■ adults and children over 12 years:
    ■ clean and dry affected area
    ■ remove backing from patch by firmly grasping both ends and
    gently pulling until backing separates in middle
    ■ carefully remove smaller portion of backing from patch and
    apply exposed portion of patch to affected area
    ■ once exposed portion of patch is positioned, carefully
    remove remaining backing to completely apply patch to
    affected area ■ use 1 patch for up to 12 hours
    ■ children 12 years or younger: ask a doctor

  • STORAGE AND HANDLING

    Other information
    ■ store at room temperature 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients alcohol, aluminum glycinate, glycerin,
    kaolin, methylparaben, polysorbate 80, propylparaben, purified
    water, sodium polyacrylate, tartaric acid, titanium dioxide

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:
    MIDWOOD BRANDS, LLC
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    49569.1

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF LIDOCAINE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-959
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALCOHOL (UNII: 3K9958V90M)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-959-011 in 1 POUCH09/07/2018
    10.04 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/07/2018
    Labeler - FAMILY DOLLAR (024472631)