FDA.reportPublic FDA data

Geliga

Manufacturer
PT. EAGLE INDO PHARMA
Effective date
2024-10-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:22:36

Label at a glance#

ProductGeliga Muscular Balm
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure10 sections

Indications and uses

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

Dosage and administration

Apply liberally and gently rub on affected area. For adults and children 12 years and older, apply to affected area not more than 3-4 times daily. For children under 12 years of age, consult a doctor before using.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

  • Menthol 13.5%
  • Methyl Salicylate 29.95%

Purpose

OTC - PURPOSE SECTION

External Analgeisc

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For external use only
  • Avoid getting into eyes or on mucous membranes

When using this product

OTC - WHEN USING SECTION

  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • 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
  • Pain persists for more than 10 days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or beast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and gently rub on affected area.
  • For adults and children 12 years and older, apply to affected area not more than 3-4 times daily.
  • For children under 12 years of age, consult a doctor before using.

Other information

OTHER SAFETY INFORMATION

Store below 86 oF (30 oC).

Inactive Ingredient(s)

INACTIVE INGREDIENT SECTION

Fragrance, paraffin, petrolatum

Questions

OTC - QUESTIONS SECTION

Contact us at 1-800-645-0769

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20g NDC: 60954-003-20

20g Unit Box20g Unit Box

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

40g NDC: 60954-003-40

40g Unit Box40g Unit Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2642205menthol 13.5 % / methyl salicylate 29.95 % Topical OintmentPSN4
2642205menthol 0.135 MG/MG / methyl salicylate 0.3 MG/MG Topical OintmentSCD4
2642205menthol 13.5 % / methyl salicylate 29.95 % Topical OintmentSY4
2642205menthol 13.5 % / methyl salicylate 30 % Topical OintmentSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60954-003-20GeligaMuscular Balm20 g in 1 BOTTLE, GLASSOINTMENT204
60954-003-20GeligaMuscular Balm1 in 1 BOXOINTMENT14
60954-003-40GeligaMuscular Balm1 in 1 BOXOINTMENT14
60954-003-40GeligaMuscular Balm40 g in 1 BOTTLE, GLASSOINTMENT404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60954-003GELIGA MUSCULAR BALM (MENTHOL, METHYL SALICYLATE) OINTMENT [PT. EAGLE INDO PHARMA]4Current NDC, 4 package rows20241004_da28097f-4b5c-6159-e053-2a95a90a7d96.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
60954-00360954-003-20, 60954-003-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
PARAFFINI9O0E3H2ZEIACT
MENTHOLL7T10EIP3AACTIB
PETROLATUM4T6H12BN9UIACT

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
Geliga Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAda28097f-4b5c-6159-e053-2a95a90a7d962024-10-02WarningsExact identifier
ndc (package): 60954-003-20
ndc (package): 60954-003-40
ndc (product): 60954-003
ndc11 (package): 60954000320
ndc11 (package): 60954000340
spl id: 237b5cf3-a723-aedc-e063-6394a90af1f7
spl set id: da28097f-4b5c-6159-e053-2a95a90a7d96

Reported adverse events (FAERS/openFDA)#

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