Parche Leon

Manufacturer: Pharmadel LLC
Effective date: 2025-03-26
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:57:58

Label at a glance#

ProductParche Leon

Active ingredientCAPSAICIN, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM

Label structure8 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with simple back aches arthritis strains bruises sprains

Dosage and administration

adults and 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: do not use, 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

Contacts and useful links#

PhoneLabel contact1-866-359-3478

Websitewww.pharmadel.com

www.pharmadel.com

Label contents#

Full prescribing information#

Active ingredients & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each patch)	Purpose
Camphor 3%.............................................................	External analgesic
Menthol 1.25%..........................................................	External analgesic
Capsaicin 0.025%.....................................	External analgesic

Uses

INDICATIONS & USAGE SECTION

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

simple back aches
arthritis
strains
bruises
sprains

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

on wounds or damaged skin
with a tight bandage
on sensitive skin
if allergic to any ingredients in this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and 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: do not use, 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

OTHER SAFETY INFORMATION

store between 59-86°F (15-30°C)
do not store in direct sunlight or expose to excessive heat
Do not use if packet containing the patch is torn or broken

Inactive Ingredients

INACTIVE INGREDIENT SECTION

None

Questions or Comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

parche leon PDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-039-01	Parche Leon	1 in 1 POUCH	PATCH	1		4
55758-039-06	Parche Leon	6 in 1 CARTON	PATCH	6		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55758-039	PARCHE LEON (CAPSAICIN, CAMPHOR, MENTHOL) PATCH [PHARMADEL LLC]	4	Current NDC, Legacy NDC, 2 package rows	20250328_a8f266fa-6e43-559e-e053-2995a90a2c75.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Parche Leon
Capsaicin, Camphor, Menthol
CAPSAICIN
CAMPHOR (SYNTHETIC)
MENTHOL, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55758-039	55758-039-01, 55758-039-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAPSAICIN	S07O44R1ZM	ACTIB
CAMPHOR (SYNTHETIC)	5TJD82A1ET	ACTIB
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Parche Leon	CAPSAICIN, CAMPHOR, MENTHOL	Pharmadel LLC	a8f266fa-6e43-559e-e053-2995a90a2c75	2025-03-26	Warnings	Exact identifier ndc (package): 55758-039-01 ndc (package): 55758-039-06 ndc (product): 55758-039 ndc11 (package): 55758003906 ndc11 (package): 55758003901 spl id: 3144b415-ab83-d639-e063-6294a90a7c93 spl set id: a8f266fa-6e43-559e-e053-2995a90a2c75

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.