FDA.reportPublic FDA data

Pain Be Gone

Manufacturer
Back to Earth Inc.
Effective date
2025-01-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:00

Label at a glance#

ProductPain Be Gone
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 9.6%

OTC - PURPOSE SECTION

Pain Relieving Gel

WARNINGS SECTION

■ For external use only.
■ Avoid Contact with the eyes. If conditions worsen, or if symptoms
persist for more that 7 days or clear up and occur again within a few
days, discontinue use of this product and consult a physician/doctor.
■ Do not apply to wounds or damaged skin.

■ Do not bandage tightly.

■ Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away.

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 of age: consult a Physician/Doctor

INDICATIONS & USAGE SECTION

■ For the temporary relief of minor aches and pains of muscles and joints
associated with simple backache, arthritis, strains, bruises, and sprains.
For penetrating pain relief.

INACTIVE INGREDIENT SECTION

Purified Water, Caprylhydroxamic Acid, Glyceryl caprylate, Glycerin,
Mentha Arvensis (Peppermint) Oil, Arnica (Arnica Montana) Macerated Oil
Rosmarinus Officinalis (Rosemary) Oil, Citrus Limonum (Lemon) Organic Oil,
Eucalyptus Globulus (Eucalyptus) Oil, Gaultheria Procumbens
(Wintergreen) Oil, Cinnamomum Camphora (White) Oil,
Pinus Sylvestris (Scotch Pine) Oil, Sodium Carbomer, Polysorbate 80.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

■ Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82721-001-01Pain Be Gone50 mL in 1 TUBECREAM503
82721-001-02Pain Be Gone120 mL in 1 TUBECREAM1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82721-001PAIN BE GONE (MENTHOL) CREAM [BACK TO EARTH INC.]3Current NDC, 2 package rows20250130_f49e718b-ef89-b648-e053-2a95a90a96c8.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82721-00182721-001-01, 82721-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
GLYCERINPDC6A3C0OXIACT
CITRUS LIMON FRUIT OIL0HNC1J1YEDIACT
ROSMARINUS OFFICINALIS FLOWERING TOP OILOXN0D3N28LIACT
EUCALYPTUS OIL2R04ONI662IACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
METHYL SALICYLATELAV5U5022YIACT
ARNICA MONTANAO80TY208ZWIACT
CAMPHOR OIL, WHITE26P3H26Z9XIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
POLYSORBATE 806OZP39ZG8HIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
MENTHA PIPERITA79M2M2UDA9IACT
MENTHOLL7T10EIP3AACTIB

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 Be GoneMENTHOLBack to Earth Inc.f49e718b-ef89-b648-e053-2a95a90a96c82025-01-29WarningsExact identifier
ndc (package): 82721-001-01
ndc (package): 82721-001-02
ndc (product): 82721-001
ndc11 (package): 82721000102
ndc11 (package): 82721000101
spl id: 2ce15484-38f2-014d-e063-6294a90aced2
spl set id: f49e718b-ef89-b648-e053-2a95a90a96c8

Reported adverse events (FAERS/openFDA)#

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