Eagle Brand Medicated Roll On Aromatic

Manufacturer
PT. EAGLE INDO PHARMA
Effective date
2026-04-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:55:10

Label at a glance#

ProductEagle Brand Medicated Roll On Aromatic
Active ingredientMETHYL SALICYLATE, CAMPHOR (SYNTHETIC), 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

  • Camphor 7%
  • Menthol 16%
  • Methyl Salicylate 35%

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

Eucalyptus oil, light mineral oil, spike lavender 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

8ml NDC: 60954-017-08

8ml Unit Box8ml Unit Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilPSN3
1654728camphor 70 MG/ML / menthol 160 MG/ML / methyl salicylate 350 MG/ML Topical OilSCD3
1654728camphor 7 % / menthol 16 % / methyl salicylate 35 % Topical OilSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138888951887510GTIN-13: 8888951887510
EAN-13: 8888951887510
GTIN storage (14 digits): 08888951887510
ARO Unit Box 8ml.jpg

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
60954-017-08Eagle BrandMedicated Roll On Aromatic8 mL in 1 BOTTLE, GLASSOIL83
60954-017-08Eagle BrandMedicated Roll On Aromatic1 in 1 BOXOIL13

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
60954-01760954-017-08

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 Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0f333f93-bec6-72d5-e063-6394a90a4e3f2026-04-27WarningsExact identifier
ndc (package): 60954-017-08
ndc (product): 60954-017
ndc11 (package): 60954001708
spl id: 507be31f-1333-bfd7-e063-6394a90ad92a
spl set id: 0f333f93-bec6-72d5-e063-6394a90a4e3f

Reported adverse events (FAERS/openFDA)#

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