Earthmed Fs Pain Relieving Balm

Earthmed Fs Pain Relieving Balm
SPL v1
SPL
SPL Set ID 3ba4e769-fec6-52d9-e063-6394a90a65d4
Route
TOPICAL
Published
Effective Date 2025-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.036 g)
Inactive Ingredients
.delta.9-tetrahydrocannabinolic Acid Peg-8 Beeswax Jojoba Oil Coconut Oil Rosemary Oil Rice Bran Oil Shea Butter Cannabidiol Arnica Montana Flower Water Maranta Arundinacea Root

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-05

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Uses

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

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY, provides penetrating pain relief

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

Other Information

Store at 68-77 degrees F, Avoid direct sunlight

Active Ingredients

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

Inactive Ingredients

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

In Case of An Overdose

seek medical help or contact a poison control center right away

When Using This Product

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

If Pregnant Or Breastfeeding

Consult a health professional before use

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

Keep Out of Reach of Children

keep out of reach of children


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Purpose

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

Warnings

FOR EXTERNAL USE ONLY, provides penetrating pain relief

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

Other Information (Other information)

Store at 68-77 degrees F, Avoid direct sunlight

Active Ingredients

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

Inactive Ingredients (Inactive ingredients)

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

In Case of An Overdose (In case of an overdose)

seek medical help or contact a poison control center right away

When Using This Product (When using this product)

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

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Consult a health professional before use

Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children (Keep out of reach of children)

keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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