FDA.reportPublic FDA data

Globe Pain Relief Spray

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2026-06-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-07-17 21:34:48

Label at a glance#

ProductPain Relief
Active ingredientMENTHOL
Label structure14 sections

Dosage and administration

Adults and Children: 12 years of age and older, spray on to affected area not more than 3 to 4 times daily. Massage not necessary. Children under 12 years of age: consult a physician wash hands after use with cool water

Storage and handling

Store at (20º-25ºC) (68ºF - 77ºF). Store in a dry place away from direct sunlight

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10.5%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Spray

Indication

INDICATIONS & USAGE SECTION

Temporary Relief of minor aches and pains of joints and muscles associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For External Use Only

Contents under pressure. Do not puncture or incinerate

Flammable: Keep away from excessive heat or open flame.

Do not store at temperature above 120ºF.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If you experience pain, swelling or blistering of the skin.
  • 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

Keep out of the 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:

12 years of age and older, spray on to affected area not more than 3 to 4 times daily. Massage not necessary.

Children under 12 years of age: consult a physician

wash hands after use with cool water

When using this product

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if ecessive irritation develops
  • do not bandage tightly or use with heating pad or device

Other information

STORAGE AND HANDLING SECTION

  • Store at (20º-25ºC) (68ºF - 77ºF).
  • Store in a dry place away from direct sunlight

If Pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Camellia Sinensis leaf extract, Butylene glycol, centella asiatica extract, Chamomilla recutita (Matricaria) flower extract, Dimethyl sulfone, isopropyl myristate, Glycyrrhiza glabra (licorice) root extract, polygonum cuspidatum root extract, Rosmarinus officinais (rosemary) leaf extract, alcohol, Scutellaria caicalensis root extract, Denatonium benzoate, water.

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

SKU: 6000

* This product is not manufactured or distributed by RB Health (US), the distributor of BioFreeze.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6000 GLOBE MENTHOL 10.5 PERCENT PAIN RELIEF SPRAY 3OZ 022526 CDER6000 GLOBE MENTHOL 10.5 PERCENT PAIN RELIEF SPRAY 3OZ 022526 CDER

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850058161358GTIN-13: 0850058161358
EAN-13: 0850058161358
GTIN-12: 850058161358
UPC-A: 850058161358
GTIN storage (14 digits): 00850058161358		6000 GLOBE MENTHOL 10.5 PERCENT PAIN RELIEF SPRAY 3OZ 022526 CDER.jpg

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
69396-17569396-175-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
POLYGONUM CUSPIDATUM ROOT7TRV45YZF7IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HIACT
ROSEMARYIJ67X351P9IACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-03-11full-release2026-06-01 01:49:40
32026-02-17monthly-update2026-06-03 17:56:33
22026-01-27monthly-update2026-06-03 17:53:18

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 ReliefMENTHOLTrifecta Pharmaceuticals USA, LLC.493ab515-5cda-7b5a-e063-6294a90a295b2026-06-19WarningsExact identifier
ndc (package): 69396-175-03
ndc (product): 69396-175
ndc11 (package): 69396017503
spl id: 54a12a51-5caa-b953-e063-6294a90ac4d4
spl set id: 493ab515-5cda-7b5a-e063-6294a90a295b

Reported adverse events (FAERS/openFDA)#

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