Label: PARCHE DE LEON- lidocaine, menthol patch

  • NDC Code(s): 55758-040-01, 55758-040-05
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Drug Facts

    Active Ingredients & Purpose

    Active ingredients (in each patch)Purpose
    Lidocaine 4% .................External analgesic
    Menthol 1% ....................

    External analgesic

  • Uses

    For the temporary relief of pain.

  • Warnings

    FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas
    • on sensitive skin
    • if allergic to any ingredients in this product

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present

    If pregnant of 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 right away.

  • Directions

    • adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor

    - clean dry affected area

    - remove patch from film

    - apply sticky side of patch to affected area

    - use one patch at a time

    - leave patch on affected area for up to 8-hours at a time

  • Other Information

    • store at room temperature 59-86 F (15-30 C)
    • do not store in direct sunlight or expose to excessive heat

    TAMPER EVIDENT: Do not use if packet containing the patch is torn or broken.

  • Inactive Ingredients

    dihydroxyaluminum aminoacetate anhydrous, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid,

    polysorbate 80, propylene glycol, povidone k90, sodium polyacrylate, tartaric acid, titanium dioxide, water

  • Principal Display Panel

    5 Patches (5.5 in x 3.94 in (13.97 cm x 10 cm) each)

    • Maximum Strength
    • Fast Acting pain relief
    • PDP Parche
  • INGREDIENTS AND APPEARANCE
    PARCHE DE LEON 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    TARTARIC ACID (UNII: W4888I119H)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-040-055 in 1 CARTON03/18/2022
    1NDC:55758-040-011 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:55758-040-011 in 1 POUCH; Type 0: Not a Combination Product03/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/18/2022
    Labeler - Pharmadel LLC (030129680)
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