FDA.reportPublic FDA data

Eagle Brand

Manufacturer
Borden Company (Private) Limited | TAIWAN SHUENN-AN BIOTECHNOLOGY PHARMACEUTICAL CO., LTD.
Effective date
2024-01-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:57

Label at a glance#

ProductEagle Brand Medicated Plaster
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure9 sections

Indications and uses

For 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 above: ▪ Clean and dry affected area before applying. ▪ Do not leave the patch on skin for more than 8 hours. ▪ 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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.0%

Methyl Salicylate 1.0%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For 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.

When using this product

OTC - WHEN USING SECTION

▪ Avoid contact with eyes or on mucous membranes.

▪ Do not apply to wounds or damaged skin.

▪ Do not bandage tightly.

▪ Do not apply wiht external heat, such as heating pad.

▪ Do not use otherwise than as directed.

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, discontinue use of this product and consult a doctor.

▪ Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occurs.

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 Centre right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and above:

▪ Clean and dry affected area before applying.

▪ Do not leave the patch on skin for more than 8 hours.

▪ 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

▪ Avoid storing product in direct sunlight.

▪ Protect product from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Clematis chinensis root, FD&C Blue No.2, Frankincense, Momordica cochinchinensis seed, Myrrh, Pinus massoniana resin, Ricinus communis seed, Sesame oil, Yellow OB, Yellow wax, Zinc oxide

Questions?

OTC - QUESTIONS SECTION

If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 Patches Pouch NDC: 43405-300-05

5 patches UB5 patches UB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1483688menthol 5 % / methyl salicylate 1 % Medicated PatchPSN1
1483688menthol 0.05 MG/MG / methyl salicylate 0.01 MG/MG Medicated PatchSCD1
1483688menthol 5 % / methyl salicylate 1 % Medicated PatchSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-300-05Eagle BrandMedicated Plaster2.3 g in 1 PATCHPATCH2.31
43405-300-05Eagle BrandMedicated Plaster5 in 1 POUCHPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-300EAGLE BRAND MEDICATED PLASTER (MENTHOL, METHYL SALICYLATE) PATCH [BORDEN COMPANY (PRIVATE) LIMITED]1Current NDC, 2 package rows20240320_1026ba99-531a-c3be-e063-6294a90a0af4.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43405-30043405-300-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SESAME OILQX10HYY4QVIACT
FRANKINCENSER9XLF1R1WMIACT
MYRRHJC71GJ1F3LIACT
ZINC OXIDESOI2LOH54ZIACT
MENTHOLL7T10EIP3AACTIB
YELLOW OBQE535CBH7SIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
PINUS MASSONIANA RESIN64S07U83T7IACT
METHYL SALICYLATELAV5U5022YACTIB
CLEMATIS CHINENSIS ROOT8Z18N528CUIACT
YELLOW WAX2ZA36H0S2VIACT
MOMORDICA COCHINCHINENSIS SEED2T87O1UPVDIACT
RICINUS COMMUNIS SEED7EK4SFN1TXIACT

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
Eagle Brand Medicated PlasterMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited1026ba99-531a-c3be-e063-6294a90a0af42024-01-30WarningsExact identifier
ndc (package): 43405-300-05
ndc (product): 43405-300
ndc11 (package): 43405030005
spl id: 1026ba99-531b-c3be-e063-6294a90a0af4
spl set id: 1026ba99-531a-c3be-e063-6294a90a0af4

Reported adverse events (FAERS/openFDA)#

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