FDA.reportPublic FDA data

Earthmed FS Pain relieving balm

Manufacturer
Earthmed LLC
Effective date
2025-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:21

Label at a glance#

ProductEarthmed FS Pain relieving balm
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

Temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains

Dosage and administration

Adults and children 12 years and over; apply to the affected area one to four times daily Children 12 years and younger; ask a doctor keep out of reach of children keep out of reach of children

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol...........11.3%

Purpose

OTC - PURPOSE SECTION

Menthol 11.3%.........................Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Menthol 11.3%.........................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY, provides penetrating pain relief

When using this product

OTC - WHEN USING SECTION

Do not apply to wounds or irritated skin, and avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

The condition worsens, symptoms last more than 7 days, the condition clears but occurs again within a few days, Rash or irritation occurs

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

Condition worsens, Symptoms last more than 7 days, Condition clears up but occurs again within a few days, Rash or irritations occurs

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a health professional before use

In case of an overdose

OVERDOSAGE SECTION

seek medical help or contact a poison control center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over; apply to the affected area one to four times daily

Children 12 years and younger; ask a doctor

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

Other information

OTHER SAFETY INFORMATION

Store at 68-77 degrees F, Avoid direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica Montana oil, Arrowroot powder, Beeswax, Full Spectrum Hemp Extract, Coconut oil, Rice bran oil, Rosemary oil, and Shea butter.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FS pain relieving balm labelFS pain relieving balm label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82876-996-49Earthmed FS Pain relieving balm71.9 g in 1 TUBESALVE71.91

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82876-99682876-996-49

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
.DELTA.9-TETRAHYDROCANNABINOLIC ACIDEJ6CZV0K5YIACT
PEG-8 BEESWAX3C1QUF1TIRIACT
JOJOBA OIL724GKU717MIACT
COCONUT OILQ9L0O73W7LIACT
MENTHOLL7T10EIP3AACTIB
ROSEMARY OIL8LGU7VM393IACT
RICE BRAN OILLZO6K1506AIACT
SHEA BUTTERK49155WL9YIACT
CANNABIDIOL19GBJ60SN5IACT
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
MARANTA ARUNDINACEA ROOTFVN346W31AIACT

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
Earthmed FS Pain relieving balmMENTHOLEarthmed LLC3ba4e769-fec6-52d9-e063-6394a90a65d42025-08-05WarningsExact identifier
ndc (package): 82876-996-49
ndc (product): 82876-996
ndc11 (package): 82876099649
spl id: 3ba4e75e-78e8-949d-e063-6294a90ae117
spl set id: 3ba4e769-fec6-52d9-e063-6394a90a65d4

Reported adverse events (FAERS/openFDA)#

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