Label: LIDOCAINE PAIN RELIEVING- lidocaine patch

  • NDC Code(s): 71391-150-01, 71391-150-05, 71391-150-06
  • Packager: Unexo Life Sciences Private Limited
  • 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 February 9, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Lidocaine 4.0%

  • PURPOSE

    Topical anesthetic

  • Uses

    Temporarily relieves minor pain.

  • Warnings

    For external use only

    Do not use

    • More than one patch on your body at a time
    • On cut, irritated or swollen skin
    • On puncture wounds
    • For more than one week without consulting a doctor
    • If you are allergic to any active or inactive ingredients
    • If pouch is damaged or opened.

    When using this product

    • Use only as directed
    • Read and follow all directions and warnings on this pack
    • Do not allow contact with the eyes
    • Do not use at the same time as other topical analgesics
    • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • Do not microwave
    • Dispose of used patch in manner that always keeps product away from children and 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 and ask a doctor if

    • Condition worsens
    • Redness is present
    • Irritation develops
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • You experience signs of skin injury, such as pain, swelling or blistering where the product was applied

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

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

  • Directions

    • Adults and children over 12 years: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard patch after single use
    • Children 12 years of age or younger: Consult a physician.
  • Other Information

    Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

  • Inactive Ingredients

    aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • Questions or Comments

    Call 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    Manufactured By:

    UNEXO LIFE SCIENCES PVT. LTD.
    B-16. Sector 4, Bawana Industrial Area,
    Delhi – 110039 (INDIA)

  • PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label

    NDC: 71391-150-01

    LIDOCAINE
    PAIN
    RELIEVING
    PATCH

    LIDOCAINE 4% / Topical Anesthetic

    Temporarily relieves pain
    Stay-Put flexible Patch
    Easy to apply & remove
    No-mess, single use application
    Odor-free

    Lasts upto 12 hours

    1 PATCH
    3.93 X 5.5 IN
    (10cm X 14cm)

    PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PAIN RELIEVING 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine344 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Kaolin (UNII: 24H4NWX5CO)  
    Methylparaben (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Tartaric Acid (UNII: W4888I119H)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71391-150-011 in 1 POUCH; Type 0: Not a Combination Product02/01/2022
    2NDC:71391-150-055 in 1 BOX02/01/2022
    2NDC:71391-150-011 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:71391-150-066 in 1 BOX02/01/2022
    3NDC:71391-150-011 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2022
    Labeler - Unexo Life Sciences Private Limited (872260479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unexo Life Sciences Private Limited872260479MANUFACTURE(71391-150)
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