FDA.reportPublic FDA data

Eagle Brand Medicated Roll On

Manufacturer
PT. EAGLE INDO PHARMA
Effective date
2026-04-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:12

Label at a glance#

ProductEagle Brand Medicated Roll On
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure8 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 14.5%
  • Methyl Salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damage 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 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

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

Chlorophyll, ethyl alcohol, mineral oil, rose oil

Questions?

OTC - QUESTIONS SECTION

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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8ml NDC: 60954-020-08

8ml Unit Box8ml 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-020-08Eagle BrandMedicated Roll On1 in 1 BOXOIL11
60954-020-08Eagle BrandMedicated Roll On8 mL in 1 BOTTLE, GLASSOIL81

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
60954-02060954-020-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
CHLOROPHYLL00WNZ48OR9IACT
ROSE OILWUB68Y35M7IACT
ALCOHOL3K9958V90MIACT
MINERAL OILT5L8T28FGPIACT

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 OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA50805eee-33b3-86bd-e063-6294a90a77d82026-04-28WarningsExact identifier
ndc (package): 60954-020-08
ndc (product): 60954-020
ndc11 (package): 60954002008
spl id: 50805eee-33b4-86bd-e063-6294a90a77d8
spl set id: 50805eee-33b3-86bd-e063-6294a90a77d8

Reported adverse events (FAERS/openFDA)#

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