FDA.reportPublic FDA data

Milagroso Methyl Salicylate 10% (WP)(DA)

Manufacturer
Pharmadel LLC
Effective date
2026-10-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-10-20 03:02:48

Label at a glance#

ProductMilagroso
Active ingredientMETHYL SALICYLATE
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache 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 12 years of age: do not use, consult a doctor

Label contents#

Full prescribing information#

Active ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Methyl salicylate 10% ..................External analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not

OTC - DO NOT USE SECTION

  • apply on wounds or irritated skin
  • bandage tightly

Stop use and ask doctor immediately if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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 immediately.

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 12 years of age: do not use, consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store between 59°- 86°F (15 - 30°C)
  • do not use if clear seal over jar is broken, torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, D&C yellow #11, lanolin oil, levomenthol, mineral oil, paraffin, petrolatum, propylparaben

Distributed by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

**Milagroso® does not contain bee venom or snake oil but contains an active ingredient that is used as an effective analgesic.**

Milagroso PDPMilagroso PDP

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-37855758-378-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR, (-)-213N3S8275IACT
LEVOMENTHOLBZ1R15MTK7IACT
D&C YELLOW NO. 1144F3HYL954IACT
PARAFFINI9O0E3H2ZEIACT
PROPYLPARABENZ8IX2SC1OHIACT
PETROLATUM4T6H12BN9UIACT
LANOLIN OILOVV5IIJ58FIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-12-04full-release2026-06-01 01:20:11

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
452656ff-79e1-0871-e063-6294a90ac49dfdcc8f44-afa0-3af0-e053-6394a90aa46d2025-12-04WarningsExact identifier
spl set id: fdcc8f44-afa0-3af0-e053-6394a90aa46d

Reported adverse events (FAERS/openFDA)#

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