Label: LOXYINE- lidocaine patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 20, 2023

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  • 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 warning on this pack
    • Do not allow contact with the eyes
    • Do not use at the same time as other topical analgesics
    • Do not bandage only 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 or skin injury, such as pain, swelling or blistering where the product was applied. 

    If pregnant or breast-feeding,

    ask a healthcare professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

  • Directions

    Adults and children 12 years of age and over: Clean and dry affected area. Remove film from patch (see illustration). Apply sticky side of patch to affected area. Use one path for up to 12 hours. Discard patch after single use. 

    Children under 12 years of age: 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?

    Toll free 1-800-587-4041 

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  • INGREDIENTS AND APPEARANCE
    LOXYINE 
    lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83658-011
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINIUM TRIGLYCINATE (UNII: 5TLG1CL557)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    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:83658-011-011 mg in 1 POUCH; Type 0: Not a Combination Product11/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/20/2023
    Labeler - Sj Incorporation Ltd (119051828)
    Registrant - Sj Incorporation Ltd (119051828)
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