Eagle Medicated Oil

Manufacturer
Eagle Indo Pharma, PT
Effective date
2024-10-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:50

Label at a glance#

ProductEagle Medicated Oil Refreshing
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure13 sections

Indications and uses

temporarily relieves the minor aches and pains of muscles and joints associated with ■simple backache ■strains ■bruises ■ sprains

Dosage and administration

■ Use only as directed ■ 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: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 14%

Methyl Salicylate 15%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the minor aches and pains of muscles and joints associated with ■simple backache ■strains ■bruises ■ sprains

Warning

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■ on wounds or damaged skin ■ with a heatng pad

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have readness over affected area

When using this product

OTC - WHEN USING SECTION

■ avoid contact with eyes or on mucous membranes ■ do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens, or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ excessive skin irritation occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenTo avoid accidental poisoning. If swallowed get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use only as directed ■ 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: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

clove oil, eucalyptus oil, fragrance, light mineral oil

Question?

OTC - QUESTIONS SECTION

1-800-777-6717 or 1-800-645-0769

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2560737menthol 14 % / methyl salicylate 15 % Topical OilPSN2
2560737menthol 140 MG/ML / methyl salicylate 150 MG/ML Topical OilSCD2
2560737menthol 14 % / methyl salicylate 15 % Topical OilSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-005-03Eagle Medicated OilRefreshing1 in 1 BOXOIL12
60954-005-03Eagle Medicated OilRefreshing3 mL in 1 BOTTLE, GLASSOIL32
60954-005-08Eagle Medicated OilRefreshing8 mL in 1 BOTTLE, GLASSOIL82
60954-005-08Eagle Medicated OilRefreshing1 in 1 BOXOIL12
60954-005-12Eagle Medicated OilRefreshing1 in 1 BOXOIL12
60954-005-12Eagle Medicated OilRefreshing12 mL in 1 BOTTLE, GLASSOIL122
60954-005-24Eagle Medicated OilRefreshing1 in 1 BOXOIL12
60954-005-24Eagle Medicated OilRefreshing24 mL in 1 BOTTLE, GLASSOIL242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-005EAGLE MEDICATED OIL REFRESHING (MENTHOL, METHYL SALICYLATE) OIL [EAGLE INDO PHARMA, PT]2Current NDC, Legacy NDC, 8 package rows20241008_e2729023-d689-7ae2-e053-2a95a90a78dc.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60954-00560954-005-24, 60954-005-08, 60954-005-03, 60954-005-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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 Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEEagle Indo Pharma, PTe2729023-d689-7ae2-e053-2a95a90a78dc2024-10-06WarningsExact identifier
ndc (package): 60954-005-03
ndc (package): 60954-005-12
ndc (package): 60954-005-08
ndc (package): 60954-005-24
ndc (product): 60954-005
ndc11 (package): 60954000512
ndc11 (package): 60954000508
ndc11 (package): 60954000503
ndc11 (package): 60954000524
spl id: 23da2b09-f7f1-57d7-e063-6394a90a8713
spl set id: e2729023-d689-7ae2-e053-2a95a90a78dc

Reported adverse events (FAERS/openFDA)#

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