Eagle

Manufacturer
Eagle Indo Pharma, PT
Effective date
2024-10-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:37

Label at a glance#

ProductEagle Medicated Aromatic
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure13 sections

Indications and uses

temporarily relieves the minor aches and pains of muscles and joint 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

Camphor 7%

Menthol 16%
Methyl Salicylate 35%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Topical Analgesic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the minor aches and pains of muscles and joint 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 heating pad

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have redness over affected area

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

■condition worsens, or if 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

eucalyptus oil, spike lavender oil, 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
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilPSN2
1654728camphor 70 MG/ML / menthol 160 MG/ML / methyl salicylate 350 MG/ML Topical OilSCD2
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-007-03EagleMedicated Aromatic1 in 1 BOXOIL12
60954-007-03EagleMedicated Aromatic3 mL in 1 BOTTLE, GLASSOIL32
60954-007-08EagleMedicated Aromatic1 in 1 BOXOIL12
60954-007-08EagleMedicated Aromatic8 mL in 1 BOTTLE, GLASSOIL82
60954-007-12EagleMedicated Aromatic1 in 1 BOXOIL12
60954-007-12EagleMedicated Aromatic12 mL in 1 BOTTLE, GLASSOIL122
60954-007-24EagleMedicated Aromatic1 in 1 BOXOIL12
60954-007-24EagleMedicated Aromatic24 mL in 1 BOTTLE, GLASSOIL242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-007EAGLE MEDICATED AROMATIC (CAMPHOR MENTHOL METHYL SALICYLATE) OIL [EAGLE INDO PHARMA, PT]2Current NDC, Legacy NDC, 8 package rows20241004_e272ec90-3cd9-5b70-e053-2a95a90a1df4.zip

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
60954-00760954-007-24, 60954-007-03, 60954-007-08, 60954-007-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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 AromaticCAMPHOR MENTHOL METHYL SALICYLATEEagle Indo Pharma, PTe272ec90-3cd9-5b70-e053-2a95a90a1df42024-10-02WarningsExact identifier
ndc (package): 60954-007-12
ndc (package): 60954-007-08
ndc (package): 60954-007-24
ndc (package): 60954-007-03
ndc (product): 60954-007
ndc11 (package): 60954000708
ndc11 (package): 60954000703
ndc11 (package): 60954000724
ndc11 (package): 60954000712
spl id: 238af46a-9570-d599-e063-6394a90aa767
spl set id: e272ec90-3cd9-5b70-e053-2a95a90a1df4

Reported adverse events (FAERS/openFDA)#

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