PARCHE LEON MILAGROSO- capsaicin, camphor, menthol patch

Parche Leon Milagroso by

Drug Labeling and Warnings

Parche Leon Milagroso by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients & Purpose

• Active ingredients (in each patch): Purpose
• Capsicum oleoresin 0.025%.....................................: External analgesic
• Camphor 3%.............................................................: External analgesic
• Menthol 1.25%..........................................................: External analgesic

Uses

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

• simple backache
• arthritis
• strains
• sprains

Warnings

For external use only. Avoid contact with the eyes.

Keep out of reach of children

In case accidental ingestion, get medical help or contact a poision Control Center right away.

Stop use and ask a doctor if

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

Do not use

• on wounds or damaged skin
• sensitive skin
• if you are allergic to any ingredients of this product

If pregnant or breast-feeding,

ask a health professional before use.

Directions

• adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a doctor
• clean and 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 Feature: Do not use if packet containing the patch is torn or broken.

Inactive ingedients

distearyl pentaerythritol diphosphite, glyceryl rosinate, light mineral oil, styrene block copolymers

Questions or Comments?

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

Distributed by:

PHARMADEL LLC

Georgetown, DE 19947

MADE IN CHINA

Principal Display Panel

Capsium

Plaster

PARCHE LEON MILAGROSO

For the Temporary Relief of:

BackPain

MuscularPain

JointPain

1 HOT PATCH

1Parche Poroso

External Analgesic Patch

INGREDIENTS AND APPEARANCE

PARCHE LEON MILAGROSO 
capsaicin, camphor, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL ROSINATE (UNII: SD112V492J)
STYRENE (UNII: 44LJ2U959V)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
DISTEARYL PENTAERYTHRITOL DIPHOSPHITE (UNII: VYL51769RX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-017-12	12 in 1 CARTON	12/05/2014	02/01/2018
1		2.27 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 55758-017-01	2.27 g in 1 POUCH; Type 0: Not a Combination Product	12/05/2014
3	NDC: 55758-017-06	6 in 1 CARTON	12/05/2014
3	NDC: 55758-017-01	2.27 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/05/2014

Labeler - Pharmadel LLC (030129680)