FDA.reportPublic FDA data

Parche Leon Milagroso

Manufacturer
Pharmadel LLC
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 23:55:49

Label at a glance#

ProductParche Leon Milagroso
Active ingredientCAPSAICIN, CAMPHOR (SYNTHETIC), MENTHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each patch) Purpose

Capsicum oleoresin 0.025%.....................................

External analgesic

Camphor 3%.............................................................

External analgesic

Menthol 1.25%..........................................................

External analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • sensitive skin
  • if you are allergic to any ingredients of this product
If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

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

Distributed by:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC

Georgetown, DE 19947

MADE IN CHINA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Capsium

Plaster

PARCHE LEON MILAGROSO

For the Temporary Relief of:

BackPain

MuscularPain

JointPain

1 HOT PATCH

1Parche Poroso

External Analgesic Patch

IFC PLMIFC PLM

Pouch_PLMPouch_PLM

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55758-017-012022-12-08C16284748780-1ba0f9c33-535a-a910-e053-dadaa90a0b85Parche Leon Milagroso Hot
55758-017-062022-12-08C16284748780-1ba0f9c33-535a-a910-e053-dadaa90a0b85Parche Leon Milagroso Hot
55758-017-122022-12-08C16284748780-1ba0f9c33-535a-a910-e053-dadaa90a0b85Parche Leon Milagroso Hot
55758-017-012021-01-29C16284748780-1ba0f9c33-535a-a910-e053-dadaa90a0b85Parche Leon Milagroso Hot
55758-017-062021-01-29C16284748780-1ba0f9c33-535a-a910-e053-dadaa90a0b85Parche Leon Milagroso Hot
55758-017-122021-01-29C16284748780-1ba0f9c33-535a-a910-e053-dadaa90a0b85Parche Leon Milagroso Hot

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET2
capsaicinACTIVE INGREDIENTS07O44R1ZM2
mentholACTIVE INGREDIENTL7T10EIP3A2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET2
capsaicinACTIVE MOIETYS07O44R1ZM2
mentholACTIVE MOIETYL7T10EIP3A2
ROSININACTIVE INGREDIENT88S87KL8772
STYRENEINACTIVE INGREDIENT44LJ2U959V2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-01755758-017-12, 55758-017-01, 55758-017-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL ROSINATESD112V492JIACT
STYRENE44LJ2U959VIACT
CAPSAICINS07O44R1ZMACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
LIGHT MINERAL OILN6K5787QVPIACT
DISTEARYL PENTAERYTHRITOL DIPHOSPHITEVYL51769RXIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ROSINROSIN88S87KL877TABLET, COATED / ORAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates
ROSINROSIN88S87KL877CAPSULE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
ROSINROSIN88S87KL877TABLET, EXTENDED RELEASE / ORAL8.99 mgExact identifier — unii candidate
3 equally ranked IID candidates

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
ef5b2aea-f7f9-b0d3-e053-2995a90a5925a363ba83-8c61-4340-abd9-e965a79fa9892022-12-08WarningsExact identifier
spl set id: a363ba83-8c61-4340-abd9-e965a79fa989

Reported adverse events (FAERS/openFDA)#

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