Label: LIDOPRO PATCH- lidocaine, menthol, and methyl salicylate patch

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

Drug Label Information

Updated February 26, 2024

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  • Active Ingredient

    Lidocaine 4%

  • Purpose

    Topical Anesthetic

  • Active Ingredient

    Menthol .5%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Methyl Salicylate .1%

  • Purpose

    Topical Counterirritant

  • Uses

    Temporarily relieves minor pain

  • Warnings

    For external use only

    Do not use

    • more than one patch on your bidy at a time or on cuts, irritated, or swollen skin

    • on puncture wounds

    • for more than one week without consulting a doctor.

    When using this product

    •
    Use only as directed. Read and follow directions and warning on this packaging.
    •
    Do not apply to wounds or damaged, broken, or irritated skin
    •
    Avoid contact with the eyes or mucous membranes
    •
    Do not bandage tightly or apply local heat (such as heating pads) to area of use
    •
    Do not use at the same time as other topical analgesics
    •
    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

    •
    conditions 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 injury, such as pain, swelling, or blistering where the product was applied

    If pregnant or breast feeding,

    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.

  • DIRECTIONS

    adults and children over 12 years:

    •
    clean and dry the affected area
    •
    remove patch from plastic liner and place on the affected area
    •
    use 1 patch for up to 12 hours
    •
    place used patch on the liner when not in use
    •
    re-use the patch up to 2 times.

    children 12 years or younger: ask a doctor

  • OTHER INGREDIENTS:

    Vegan Glycerol, Polyacrylate, Aqua. Polysorbate 80

  • Principal Display Panel

    LidoPro patch

    Relabeled By: Preferred Pharmaceuticals Inc.

    LidoPro® Patch

    NDC 68788-8594-3

  • INGREDIENTS AND APPEARANCE
    LIDOPRO PATCH 
    lidocaine, menthol, and methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8594(NDC:83881-401)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg  in 100 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 mg  in 100 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.1 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8594-315 in 1 BOX02/26/2024
    12 in 1 POUCH
    18500 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/26/2024
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8594)
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