PARCHE DE LEON- lidocaine, menthol patch 
Pharmadel LLC

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.

----------

Parche Leon Gel Patch (SHANGHAI G)

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

- 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

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)

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)

Revised: 12/2022
Document Id: ef5b0db6-8f0b-4f8e-e053-2995a90a22b7
Set id: da833ccc-9a94-6bfc-e053-2a95a90a4da3
Version: 3
Effective Time: 20221208
 
Pharmadel LLC