Globe Maximum Strength Pain & Itch Relief Cream

Manufacturer
Trifecta Pharmaceutical USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:06

Label at a glance#

ProductPain Itch Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

Adults and children over 12 years: Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. Children 12 years or younger: ask a doctor

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

Use only as directed.

Do not allow contact with eyes.

Do not bandage or apply local heat such as heating pads to the area of use

Do Not Use

OTC - DO NOT USE SECTION

On large areas of the body or on cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

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.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

Apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period.

Children 12 years or younger: ask a doctor

Questions

OTC - QUESTIONS SECTION

For Questions please call 1 888 296 9067

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl Sterate, Light Mineral Oil, Petrolatum, Polyoxyethylene Lauryl Ether, Purified Water, Sodium Lauryl Sulfate.

Distributed By

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

This product is not manufactured or distributed by Chattem, Inc. a Sanofi Company owner of the registered trademark Gold Bond.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Globe Lidocaine Cream 49.6g CDERGlobe Lidocaine Cream 49.6g CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN2
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD2
1010895lidocaine hydrochloride 4 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-120-17Pain Itch Relief49.6 g in 1 BOTTLECREAM49.62
69396-120-17Pain Itch Relief1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-120PAIN ITCH RELIEF (LIDOCAINE HCI) CREAM [TRIFECTA PHARMACEUTICAL USA LLC]2Current NDC, 2 package rows20241222_f40b19a8-795c-f514-e053-2a95a90a6d15.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-12069396-120-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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 Itch ReliefLIDOCAINE HCITrifecta Pharmaceutical USA LLCf40b19a8-795c-f514-e053-2a95a90a6d152024-12-20WarningsExact identifier
ndc (package): 69396-120-17
ndc (product): 69396-120
ndc11 (package): 69396012017
spl id: 29b3acd1-d36c-c0b4-e063-6394a90a5234
spl set id: f40b19a8-795c-f514-e053-2a95a90a6d15

Reported adverse events (FAERS/openFDA)#

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