PARCHE LEON- capsaicin, camphor, menthol patch

Parche Leon by

Drug Labeling and Warnings

Parche Leon 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
• Camphor 3%.............................................................: External analgesic
• Menthol 1.25%..........................................................: External analgesic
• Capsaicin 0.025%.....................................: External analgesic

Uses

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

• simple back aches
• arthritis
• strains
• sprains

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes .

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
• 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

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

Inactive Ingredients

None

Questions or Comments?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

NDC: 55758-039-06

PARCHE LEON

External Analgesic

Penetrating pain relief of:

• Back Aches
• Muscles
• Arthritis

6 Adhesive Plaster Patches

4.72 in x 7.07 in (12 cm x 18 cm)

Pain Relieving

HOT PATCH

INGREDIENTS AND APPEARANCE

PARCHE LEON 
capsaicin, camphor, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-039
Route of Administration	TOPICAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-039-01	1 in 1 POUCH; Type 0: Not a Combination Product	02/28/2020
2	NDC: 55758-039-06	6 in 1 CARTON	02/28/2020
2	NDC: 55758-039-01	1 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	02/28/2020

Labeler - Pharmadel LLC (030129680)