FDA.reportPublic FDA data

Globe Pain Relief Gel Roll On Lidocaine HCI 4%

Manufacturer
Trifecta Pharmaceuticals USA
Effective date
2026-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:41

Label at a glance#

ProductPain Relief Gel-Roll On
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure16 sections

Dosage and administration

Adults and children over 12 years: apply a thin layer to the affected area not more than 3 to 4 times daily. Children 12 years or younger: ask a doctor

Storage and handling

Store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

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.

Warning Section

WARNINGS SECTION

For External Use Only

Flammable - keep away from fire or flames.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children over 12 years: apply a thin layer to the affected area not more than 3 to 4 times daily.
  • Children 12 years or younger: ask a doctor

Do Not Use

OTC - DO NOT USE SECTION

Do Not Use

  • On large areas of the body or on cut, irritatied or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When Using this product

OTC - WHEN USING SECTION

When using this product

  • use only as directed. Read and follow all directions and warnings on this carton
  • Do not allow contact with the eyes and mucous membranes
  • do not bandage or apply local heat (such as heating pads) or a medicated patch to the area of use.
  • Do not use at the same time as other topical analgesics.

Indications and use

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain.

Other Information

STORAGE AND HANDLING SECTION

  • Store at 20° to 25°C (68° to 77°F)

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Aloe Vera Extract, Carbomer, Isopropyl Myristate, Polysorbate 80, Propylene glycol, Vitamin E, Water, 1,2 Hexanediol, Aminomethylpropanol, Butylene Glycol, Cetostearyl alcohol, Dimethicone, Edetate Disodium, Glycerin, Glycerol Mono and Dipalmitostearate, hydroxyacetophenone

Stop Use and Ask Doctor if

OTC - STOP USE SECTION

Stop use and ask doctor if

  • Condition worsens
  • Redness is present
  • irritation devlops
  • symptoms persisit for more than 7 days or clear up and occur again within a few days

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: 6003

* This product is not manufactured or distributed by Chattem Inc., the distributor of Aspercreme®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6003 GLOBE PAIN RELIEF GEL-ROLL ON LIDOCAINE HCL 4 PERCENT 2.5OZ LOOSE 051226 CDER6003 GLOBE PAIN RELIEF GEL-ROLL ON LIDOCAINE HCL 4 PERCENT 2.5OZ LOOSE 051226 CDER

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

600302-FBA GLOBE PAIN RELIEF GEL-ROLL ON LIDOCAINE HCL 4 PERCENT 2.5OZ 2PK CDER600302-FBA GLOBE PAIN RELIEF GEL-ROLL ON LIDOCAINE HCL 4 PERCENT 2.5OZ 2PK CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN1
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD1
1010077lidocaine hydrochloride 4 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850058161402GTIN-13: 0850058161402
EAN-13: 0850058161402
GTIN-12: 850058161402
UPC-A: 850058161402
GTIN storage (14 digits): 00850058161402		600302-FBA GLOBE PAIN RELIEF GEL-ROLL ON LIDOCAINE HCL 4 percent 2.5OZ 2PK CDER.jpg
BarcodeEAN-130850058161556GTIN-13: 0850058161556
EAN-13: 0850058161556
GTIN-12: 850058161556
UPC-A: 850058161556
GTIN storage (14 digits): 00850058161556		6003 GLOBE PAIN RELIEF GEL-ROLL ON LIDOCAINE HCL 4 percent 2.5OZ LOOSE 051226 CDER.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-188-01Pain Relief Gel-Roll On1 in 1 BOXGEL11
69396-188-01Pain Relief Gel-Roll On0.073 L in 1 BOTTLEGEL0.0731
69396-188-02Pain Relief Gel-Roll On2 in 1 BOXGEL21
69396-188-02Pain Relief Gel-Roll On0.073 L in 1 BOTTLEGEL0.0731

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-18869396-188-01, 69396-188-02

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
EDETATE DISODIUM7FLD91C86KIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONO- AND DIPALMITOSTEARATEKC98RO82HJIACT
POLYSORBATE 806OZP39ZG8HIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
WATER059QF0KO0RIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
CARBOMER0A5MM307FCIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
HYDROXYACETOPHENONEG1L3HT4CMHIACT
GLYCERINPDC6A3C0OXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT

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 OnLIDOCAINETrifecta Pharmaceuticals USA51cb6797-55ec-7a7a-e063-6294a90a90ee2026-05-14WarningsExact identifier
ndc (package): 69396-188-01
ndc (package): 69396-188-02
ndc (product): 69396-188
ndc11 (package): 69396018802
ndc11 (package): 69396018801
spl id: 51cb4dd4-428b-662a-e063-6294a90ac4df
spl set id: 51cb6797-55ec-7a7a-e063-6294a90a90ee

Reported adverse events (FAERS/openFDA)#

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