Label: MANAMED LIDOCAINE 4% PAIN RELIEVING GEL PATCH- lidocaine patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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

  • Active ingredient

    Lidocaine 4%

  • 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 is product

    • Use only as direacted
    • Read and follow all direactions and warnings on this carton
    • Do not allow contact with 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 the use
    • Do not microwave
    • Dispose of used patch in the manner that always keeps product away from childen 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 consult a doctor if

    • Condition worsens
    • Redness is present
    • Irritation develops
    • Symtoms persists 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 breastfeading, ask health professional before use.

    Keep out of reach of children and pets If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Adults and children 12 years of age and over:

    Clean and dry affected area.Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area.Use one patch for up to 8 hrs

    Children under 12 years of age : consult a physician

  • Other information

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

  • Inactive ingredients

    Water, Glycerin, Propylene Glycol, PVP, Sodium Polyacrylate, Methylparaben, Propylparaben, Aluminum Glycinate, Kaolin, Polyacrylic Acid, Polysorbate 80, Tartaric Acid, Titanium Dioxide

  • Product label

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  • INGREDIENTS AND APPEARANCE
    MANAMED LIDOCAINE 4% PAIN RELIEVING GEL PATCH 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82728-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82728-001-016 in 1 BOX06/22/2022
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/22/2022
    Labeler - Manamed, Inc. (084042331)