EARTHMED FS PAIN RELIEVING BALM- menthol salve

Earthmed FS Pain relieving balm by

Drug Labeling and Warnings

Earthmed FS Pain relieving balm by is a Otc medication manufactured, distributed, or labeled by Earthmed LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

Purpose

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

Purpose

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

Uses

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

Warnings

FOR EXTERNAL USE ONLY, provides penetrating pain relief

When using this product

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

Stop use and ask a doctor if

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

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

Consult a health professional before use

In case of an overdose

seek medical help or contact a poison control center right away

Directions

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

Keep out of reach of children

keep out of reach of children

Other information

Store at 68-77 degrees F, Avoid direct sunlight

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARTHMED FS PAIN RELIEVING BALM 
menthol salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-996
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.9 g  in 71.9 g

Inactive Ingredients
Ingredient Name	Strength
.DELTA.9-TETRAHYDROCANNABINOLIC ACID (UNII: EJ6CZV0K5Y)	0.036 g  in 71.9 g
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)	19.02 g  in 71.9 g
JOJOBA OIL (UNII: 724GKU717M)	5.1 g  in 71.9 g
COCONUT OIL (UNII: Q9L0O73W7L)	8.21 g  in 71.9 g
ROSEMARY OIL (UNII: 8LGU7VM393)	0.59 g  in 71.9 g
RICE BRAN OIL (UNII: LZO6K1506A)	11.51 g  in 71.9 g
SHEA BUTTER (UNII: K49155WL9Y)	12.204 g  in 71.9 g
CANNABIDIOL (UNII: 19GBJ60SN5)	2.25 g  in 71.9 g
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)	4.22 g  in 71.9 g
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)	0.86 g  in 71.9 g

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82876-996-49	71.9 g in 1 TUBE; Type 0: Not a Combination Product	08/05/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/05/2025

Labeler - Earthmed LLC (118697474)

Registrant - Earthmed LLC (118697474)

Establishment
Name	Address	ID/FEI	Business Operations
Earthmed LLC		118697474	manufacture(82876-996)