Label: LIDOCAINE patch

  • NDC Code(s): 81877-514-15
  • Packager: FORREAL PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 10, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 4%

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    For the temporary relief of pain

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use

    • More than 1 pathch at a time
    • On wounds or damaged skin
    • With a heating pad
    • If you are allergic to any ingredients of this product
  • WHEN USING

    When using this product

    • Use only as directed
    • Avoid contact with the eyes, mucous membranes or rashes
    • Do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • Conditions worsen
    • Symptoms persist for more than 7 days
    • Symptoms clear up and occur again within a few days
  • 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 right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and over:

    • Clean and dry the affected area
    • Open pouch and remove one patch
    • Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
    • Reseal pouch containing unused patches after each use
    • Remove patch from the skin after at most 8-hour application ​

    ​Children under 12 years of age: Consult a doctor

  • Other information:

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
  • INACTIVE INGREDIENT

    Other ingredients: Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

    Questions or comments? 866-747-7365

  • PRINCIPAL DISPLAY PANEL

    Packaged For:

    Forreal Pharmaceuticals LLC

    Royal Oak, MI 48067

    Questions or Comments please call 877-367-3250

    NDC 81877-514-15

    Qty:15 Patches

    (5 per Resealable Pouch) x 3

    Lidocaine 4%

    Topical Pain Patch

    for temporary pain relief

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-514
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    KAOLIN (UNII: 24H4NWX5CO)  
    SILODRATE ANHYDROUS (UNII: 59110L5W24)  
    2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLE (White Flexible Patch) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81877-514-153 in 1 BOX06/27/2022
    11 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/27/2022
    Labeler - FORREAL PHARMACEUTICALS LLC (118029197)
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