PARCHE LEON MILAGROSO DUAL ACTION- capsaicin, 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.

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Parche Leon Milagroso Dual Action

Drug Facts

Active Ingredients

Capsaicin 0.0375%

Menthol 5%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes.

Allergy Alert: This product contains natural rubber latex which may cause allergy reactions.

Do not use

  • on wounds or damaged skin
  • with a bandage or heating pad
  • 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 or 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

Inactive ingredients:

aloe barbadensis leaf (aloe vera gel) juice, diazolidinyl urea, EDTA disodium, glycerin, iodopropynyl butylcarbamate, methylparaben, polysorbate 80, propylparaben, sodium polyacrylate, water.

Other information:

TAMPER EVIDENT:

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

Questions & comments?

1-899-359-3478 (M-F) 9 AM to 5 PM Eastern or www.pharmadelusa.com

Topical Analgesic Patches

Dual Action Pain Relief

For the temporary relief of:

PDP Panel

PARCHE LEON MILAGROSO  DUAL ACTION
capsaicin, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-046
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-046-066 in 1 CARTON02/01/2016
12.27 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2016
Labeler - Pharmadel LLC (026095439)

Revised: 7/2016
Document Id: 36969358-04f2-5cad-e054-00144ff88e88
Set id: 36969358-04f1-5cad-e054-00144ff88e88
Version: 1
Effective Time: 20160701
 
Pharmadel LLC