FDA.reportPublic FDA data

Globe First Aid Burn Gel

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-11 03:02:06

Label at a glance#

ProductBurn Gel
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporary pain relief for minor burns. For professional use only.

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: do not use, consult a doctor

Storage and handling

Store at room temperature (do not freeze) do not use any opened or torn packets

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 2%

Purpose

OTC - PURPOSE SECTION

Topical Pain Relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief for minor burns. For professional use only.

Warnings

WARNINGS SECTION

For external Use Only

Do not use

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

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: do not use, consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Phenoxyethanol, Propylene glycol, purified water, Triethanolamine, Vitamin E acetate

Questions?

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Stop Use and Ask a doctor if

OTC - STOP USE SECTION

The condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Storage Information

STORAGE AND HANDLING SECTION

  • Store at room temperature (do not freeze)
  • do not use any opened or torn packets

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 immediately.

Other Information

SPL UNCLASSIFIED SECTION

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

* THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

** INDIVIDUAL PACKETS NOT CHILD-RESISTANT.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4048 GLOBE BURN GEL 0.9G 144 CT 082826 CDER4048 GLOBE BURN GEL 0.9G 144 CT 082826 CDER

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850026393484GTIN-13: 0850026393484
EAN-13: 0850026393484
GTIN-12: 850026393484
UPC-A: 850026393484
GTIN storage (14 digits): 00850026393484		4048 GLOBE BURN GEL 0.9G 144CT 082826 CDER.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-106-09EA - Each69396-106e1d05818-54e5-4c45-8396-912ab764dc2312024-10-04

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-10669396-106-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM HYDROXIDE55X04QC32IIACT
MALTODEXTRIN7CVR7L4A2DIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-08-29daily-update2026-09-01 13:02:06
32024-07-12full-release2026-06-01 00:15:13

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
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
ndc (package): 69396-106-09
ndc (product): 69396-106
ndc11 (package): 69396010609
spl id: 5b10e1d6-5f38-693f-e063-6294a90ac847
spl set id: e9d3e9be-1036-fad0-e053-2a95a90a6efe

Reported adverse events (FAERS/openFDA)#

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