FDA.reportPublic FDA data

Eagle Brand

Manufacturer
PT. EAGLE INDO PHARMA
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:11

Label at a glance#

ProductEagle Brand Medicated Oil
Active ingredientMETHYL SALICYLATE, 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 • bruises • sprains.

Dosage and administration

Adults and children 2 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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

  • Menthol 14.5%
  • Methyl Salicylate 30%

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 getting into the eyes or on mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use otherwise than as directed.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
  • Excessive skin irritation develops.

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 2 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.

Other information

OTHER SAFETY INFORMATION

Store below 86 oF (30 oC).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, beta carotene, D&C Green No.6, eucalyptus oil, fragrance, light mineral oil, peppermint oil, rose oil

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

24ml NDC: 60954-015-24

24ml Unit Box24ml Unit Box

36ml NDC: 60954-015-36

36ml Unit Box36ml Unit Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293435EAGLE BRAND Medicated 14.5 % / 30 % Topical OilPSN1
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilPSN1
1293435menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical Oil [Eagle Brand Medicated Oil]SBD1
1293430menthol 145 MG/ML / methyl salicylate 300 MG/ML Topical OilSCD1
1293435Eagle Brand Medicated Oil (menthol 14.5 % / methyl salicylate 30 % ) Topical OilSY1
1293435Eagle Brand Medicated Oil (menthol 14.5 GM / methyl salicylate 30 GM per 100 ML) Topical OilSY1
1293430menthol 14.5 % / methyl salicylate 30 % Topical OilSY1

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
60954-015-24Eagle BrandMedicated Oil24 mL in 1 BOTTLE, GLASSOIL241
60954-015-24Eagle BrandMedicated Oil1 in 1 BOXOIL11
60954-015-36Eagle BrandMedicated Oil1 in 1 BOXOIL11
60954-015-36Eagle BrandMedicated Oil36 mL in 1 BOTTLE, GLASSOIL361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-015EAGLE BRAND MEDICATED OIL (MENTHOL, METHYL SALICYLATE) OIL [PT. EAGLE INDO PHARMA]1Current NDC, 4 package rows20240627_1bc1bf83-91ee-ec9d-e063-6394a90a3daf.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60954-01560954-015-24, 60954-015-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ROSE OILWUB68Y35M7IACT
ALCOHOL3K9958V90MIACT
D&C GREEN NO. 64QP5U84YF7IACT
BETA CAROTENE01YAE03M7JIACT
PEPPERMINT OILAV092KU4JHIACT
EUCALYPTUS OIL2R04ONI662IACT
LIGHT MINERAL OILN6K5787QVPIACT
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB

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 OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA1bc1bf83-91ee-ec9d-e063-6394a90a3daf2024-06-25WarningsExact identifier
ndc (package): 60954-015-36
ndc (package): 60954-015-24
ndc (product): 60954-015
ndc11 (package): 60954001524
ndc11 (package): 60954001536
spl id: 1bc1f58b-341c-384b-e063-6394a90ab995
spl set id: 1bc1bf83-91ee-ec9d-e063-6394a90a3daf

Reported adverse events (FAERS/openFDA)#

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