Drug Facts

Manufacturer
Green Earth Health Inc. | Maitland Labs of Central Florida | Organics Corporation of America DBA Ambix Laboratories
Effective date
2019-12-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:50:35

Label at a glance#

ProductPAIN RELIEF MENTHOL AND HEMP
Active ingredientLEVOMENTHOL, CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP
Label structure7 sections

Dosage and administration

• Liberally apply gel to affected area and rub into joints. • Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort. • Use no more than 4 times per day. • Allow several days for product to take maximum effect.

Label contents#

Full prescribing information#

Active Ingredients                                                                                  Purpose

OTC - ACTIVE INGREDIENT SECTION

Hemp extract (Cannabis sativa) 1X 7%(15.7mg) HPUS                          Anti-inflammatory
Menthol (Mentholum) Tinc. 0.1% (1mg) HPUS                                       Analgesic

Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Indication:

INDICATIONS & USAGE SECTION

Temporarily relieves pain associated with arthritis, backache, bruises, muscle cramps, sprains, and strains.

Warnings:

WARNINGS SECTION

• For external use only. Not for use on open wounds.
• If symptoms persist or worsen, discontinue use, seek medical attention.
• Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
• If rash, redness, irritation or itching occurs, discontinue use.
• If pregnant or breastfeeding ask a health professional before use.
• If swallowed, get medical help or contact a Poison Center.
• Keep out of reach of children.

Directions For Use:

DOSAGE & ADMINISTRATION SECTION

• Liberally apply gel to affected area and rub into joints.
• Use 3-4 times per day for the first week. Use as needed thereafter to relieve discomfort.
• Use no more than 4 times per day.
• Allow several days for product to take maximum effect.

Other Information:

SPL UNCLASSIFIED SECTION

• Published clinical reports suggest that active ingredients may provide relief from other types of pain and inflammation.
• Consult a medical professional if using other medications for known interactions.
• Cannabidiol in hemp extract may alter the metabolism of other drugs.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Benzalkonium chloride NF, C13-14 isoparaffin, laureth-7, polyacrylamide, purified water, virgin olive oil, vitamin E.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73002-31273002-312-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

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
c4cb85d6-9da0-4f55-8db7-b3e9d9e6bd56b67f5f7b-0f79-4c47-910a-8fd9b1d5a7dd2020-09-14WarningsExact identifier
spl set id: b67f5f7b-0f79-4c47-910a-8fd9b1d5a7dd

Reported adverse events (FAERS/openFDA)#

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