EARTHMED FS MASSAGE OIL- allantoin oil

Earthmed FS massage oil by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Allantoin......1%

Purpose

Skin protectant

Uses

Helps prevent and temporarily protect and help relieve chafed, chapped, or cracked skin.

Helps prevent and protect from the drying of wind and cold weather

Warnings

For external use only.

Do not use

on deep or puncture wounds, animal bites, serious burns

When using this product

Do not get into eyes

Stop use and ask doctor if

condition worsens, symptoms last for more than 7 days, condition clears up but occurs again within a few days, rash or irritation occurs

Stop use and ask doctor if

Condition worsens, Symptoms last for more than 7 days, condition clears up but occurs again in a few days, rash or irritation occurs

If pregnant or breast feeding

Consult a health professional before use.

in case of overdose

seek medical help or contact a poison control center right away

Directions

shake well before use.

adults and children 2 years and over; apply as needed.

children under 2 years; consult a doctor

keep out of reach of children

Keep out of reach of children

Other information

Store at 68-77 degrees F (20-25 degrees C), avoid direct sunlight

inactive ingredients

Arnica montana, Cannabidiol, Jojoba oil, Lavender oil, Peppermint oil, Rice bran oil, Sweet almond oil.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARTHMED FS MASSAGE OIL 
allantoin oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82876-986
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	1 g  in 108.48 g

Inactive Ingredients
Ingredient Name	Strength
RICE BRAN OIL (UNII: LZO6K1506A)	65.235 g  in 108.48 g
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.28 g  in 108.48 g
PEPPERMINT OIL (UNII: AV092KU4JH)	0.15 g  in 108.48 g
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)	2.85 g  in 108.48 g
ALMOND OIL (UNII: 66YXD4DKO9)	27.2 g  in 108.48 g
JOJOBA OIL (UNII: 724GKU717M)	10.58 g  in 108.48 g
CANNABIDIOL (UNII: 19GBJ60SN5)	1.13 g  in 108.48 g
.DELTA.9-TETRAHYDROCANNABINOLIC ACID (UNII: EJ6CZV0K5Y)	0.055 g  in 108.48 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: 82876-986-34	108.48 g in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/04/2025

Labeler - Earthmed LLC (118697474)

Registrant - Earthmed LLC (118697474)

Establishment
Name	Address	ID/FEI	Business Operations
Earthmed LLC		118697474	manufacture(82876-986)