FDA.reportPublic FDA data

Globe Pain Relief Gel-Roll On

Manufacturer
Trifecta Pharmaceuticals USA
Effective date
2026-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:55:54

Label at a glance#

ProductPain Relief Gel Roll On
Active ingredientMENTHOL
Label structure14 sections

Dosage and administration

Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor Wash hands after use with cold water.

Storage and handling

Store at 20° to 25°C (68° to 77°F) Store in cool dry place away from direct sunlight

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Warnings

WARNINGS SECTION

For external use only.

Flammable Keep away from excessive heat or open flames.

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If Swallowed, get medical help or contact a Poison Control Center right away

If Pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If Pregnant or breast feeding as a doctor before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: ask a doctor
  • Wash hands after use with cold water.

Indications and use

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Other Information

STORAGE AND HANDLING SECTION

  • Store at 20° to 25°C (68° to 77°F)
  • Store in cool dry place away from direct sunlight

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Vera extract, Arnica Montana Flower extract, Boswellia carteril resin extract, Camellia sinesis leaf extract, Camphor, Carbomer, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex parguariensis leaf extract, Isopropyl myristate, Silica, Triethanolamine, Vitamin E, Water.

Stop Use and Ask Doctor if

OTC - STOP USE SECTION

Stop use and ask doctor if

  • you experience pain, swelling or blistering of the skin
  • if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age.

Questions?

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA ®

101 NE Third Avenue, Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 4091-FBA

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4091-FBA Globe Pain Relief Gel-Roll On 24091-FBA Globe Pain Relief Gel-Roll On 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

409103-Globe-menthol-roll-on-3pk-CDER409103-Globe-menthol-roll-on-3pk-CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN1
415974menthol 0.04 MG/MG Topical GelSCD1
415974menthol 4 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850058161495GTIN-13: 0850058161495
EAN-13: 0850058161495
GTIN-12: 850058161495
UPC-A: 850058161495
GTIN storage (14 digits): 00850058161495		409103-Globe-menthol-roll-on-3pk-CDER.jpg
BarcodeEAN-130850058161501GTIN-13: 0850058161501
EAN-13: 0850058161501
GTIN-12: 850058161501
UPC-A: 850058161501
GTIN storage (14 digits): 00850058161501		4091-FBA Globe Pain Relief Gel-Roll On 2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-184-01Pain Relief Gel Roll On1 in 1 BOXGEL11
69396-184-01Pain Relief Gel Roll On0.074 L in 1 BOTTLEGEL0.0741
69396-184-03Pain Relief Gel Roll On0.074 L in 1 BOTTLEGEL0.0741
69396-184-03Pain Relief Gel Roll On3 in 1 BOXGEL31

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-18469396-184-01, 69396-184-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
SILICAETJ7Z6XBU4IACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
TRIETHANOLAMINE9O3K93S3TKIACT
CAMELLIA SINENSIS LEAF OILVC855RRT77IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
FRANKINCENSER9XLF1R1WMIACT
CARBOMER0A5MM307FCIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
GLYCERINPDC6A3C0OXIACT

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
Pain Relief Gel Roll OnMENTHOLTrifecta Pharmaceuticals USA50b1a420-d5cd-6d61-e063-6294a90a04512026-04-30WarningsExact identifier
ndc (package): 69396-184-03
ndc (package): 69396-184-01
ndc (product): 69396-184
ndc11 (package): 69396018401
ndc11 (package): 69396018403
spl id: 50b1a42e-f7ee-74db-e063-6294a90a7d89
spl set id: 50b1a420-d5cd-6d61-e063-6294a90a0451

Reported adverse events (FAERS/openFDA)#

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