FDA.reportPublic FDA data

Parche Leon Milagroso

Manufacturer
Pharmadel LLC
Effective date
2016-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:25:02

Label at a glance#

ProductParche Leon Milagroso Dual Action
Active ingredientMENTHOL, CAPSAICIN
Label structure9 sections

Indications and uses

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

Dosage and administration

adults & children 12 yrs of age & older: apply to affected area not more than 3 to 4 times daily children under 2 year 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

Storage and handling

store at room temperature 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.0375%

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backaches
  • arthritis
  • strains
  • sprains

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

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 & children 12 yrs of age & older: apply to affected area not more than 3 to 4 times daily
  • children under 2 year 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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

Other information:

STORAGE AND HANDLING SECTION

  • store at room temperature 59-86°F (15-30°C)
  • do not store in direct sunlight or expose to excessive heat

TAMPER EVIDENT:

OTHER SAFETY INFORMATION

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

Questions & comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Analgesic Patches

Dual Action Pain Relief

For the temporary relief of:

  • Sore Muscules
  • Backache
  • Arthritis
  • Joint Pain

PDP PanelPDP Panel

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-04655758-046-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
METHYLPARABENA2I8C7HI9TIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
CAPSAICINS07O44R1ZMACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
291b710d-fb3f-ddd4-e063-6394a90ab28736969358-04f1-5cad-e054-00144ff88e882024-12-12WarningsExact identifier
spl set id: 36969358-04f1-5cad-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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