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
  • 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 December 8, 2022

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

View All Sections
  • 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 not finalpart34803/18/2022
    Labeler - Pharmadel LLC (030129680)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!