FDA.reportPublic FDA data

Eagle Brand

Manufacturer
PT. EAGLE INDO PHARMA
Effective date
2025-08-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:34:57

Label at a glance#

ProductEagle Brand Yellow Balm
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure9 sections

Indications and uses

For the 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 15.5%
  • Camphor 4%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the 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 mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use if excessive irritation of the skin develops.
  • 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.

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

Beta carotene, eucalyptus oil, methyl salicylate, paraffin, peppermint 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.PRINCIPAL DISPLAY PANEL

10g NDC: 60954-298-10

10g unit box10g unit box

20g NDC: 60954-298-20

20g unit box20g unit box

40g NDC: 60954-298-40

40g unit box40g unit box

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
60954-29860954-298-10, 60954-298-20, 60954-298-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
METHYL SALICYLATELAV5U5022YIACT
PARAFFINI9O0E3H2ZEIACT
BETA CAROTENE01YAE03M7JIACT
EUCALYPTUS OIL2R04ONI662IACT
PEPPERMINT OILAV092KU4JHIACT

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
49fbbb57-516e-333b-e063-6394a90a82733cafdc50-adf0-9d89-e063-6294a90a07bf2026-02-04WarningsExact identifier
spl set id: 3cafdc50-adf0-9d89-e063-6294a90a07bf

Reported adverse events (FAERS/openFDA)#

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