FDA.reportPublic FDA data

Eagle Green Balm

Manufacturer
Borden Company (Private) Limited | PT. EAGLE INDO PHARMA
Effective date
2024-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:34:13

Label at a glance#

ProductEagle Green Balm
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure11 sections

Indications and uses

For the temporary relief of minor pains and aches of muscles and joints associated with ■ simple backache ■arthritis ■strains ■bruises ■sprains

Dosage and administration

■ Adults and children 12 years of age: apply to affected area not more than 3 - 4 times daily. ■ children under 12 years of age, consult a doctor before use Section 8 changed to reflect change in children's age for usage (from 2 years of age to 12 years of age) (July 2021)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 15%

Camphor 11%

Purpose

OTC - PURPOSE SECTION

External Analgesic

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor pains and aches 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 and damaged skin ■ do not bandage tightly or use with a heating pad ■ do not use otherwise than as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ Condition worsens, ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ redness is present

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children in case of accidental ingestion contact a doctor or Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 12 years of age: apply to affected area not more than 3 - 4 times daily. ■ children under 12 years of age, consult a doctor before use

Directions

RECENT MAJOR CHANGES SECTION

Section 8 changed to reflect change in children's age for usage (from 2 years of age to 12 years of age) (July 2021)

Other Information

SPL UNCLASSIFIED SECTION

■ Store in a cool dry place

Inactive Ingredients

INACTIVE INGREDIENT SECTION

fragrance, paraffin, peppermint oil, petrolatum

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2048211camphor 11 % / menthol 15 % Topical OintmentPSN4
2048211camphor 0.11 MG/MG / menthol 0.15 MG/MG Topical OintmentSCD4
2048211camphor 11 % / menthol 15 % Topical OintmentSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43405-100-01Eagle Green Balm1 in 1 BOXOINTMENT14
43405-100-20Eagle Green Balm20 g in 1 JAROINTMENT204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43405-100EAGLE GREEN BALM (CAMPHOR MENTHOL) OINTMENT [BORDEN COMPANY (PRIVATE) LIMITED]4Current NDC, Legacy NDC, 2 package rows20241106_6f7a796b-a31c-0e60-e053-2a91aa0a022b.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43405-10043405-100-20, 43405-100-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PEPPERMINT OILAV092KU4JHIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB

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 Green BalmCAMPHOR MENTHOLBorden Company (Private) Limited6f7a796b-a31c-0e60-e053-2a91aa0a022b2024-11-04WarningsExact identifier
ndc (package): 43405-100-01
ndc (package): 43405-100-20
ndc (product): 43405-100
ndc11 (package): 43405010001
ndc11 (package): 43405010020
spl id: 2621b9b1-652a-5850-e063-6394a90aef8c
spl set id: 6f7a796b-a31c-0e60-e053-2a91aa0a022b

Reported adverse events (FAERS/openFDA)#

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