PAIN RELIEF MENTHOL AND HEMP (hemp extract (cannabis sativa) 1x, menthol- mentholum tinc. lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients                                                                                  Purpose

Hemp extract (Cannabis sativa) 1X 7%(15.7mg) HPUS                          Anti-inflammatory
Menthol (Mentholum) Tinc. 1% (10mg) HPUS                                       Analgesic

Approximately 56 applications per container

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

PURPOSE

Indication:

Temporarily relieves pain associated with arthritis, joint pain and muscle cramps

KEEP OUT OF REACH OF CHILDREN

Warnings:

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:

• Liberally apply lotion 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.
• Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)

Other Information:

Consult a medical professional if using other medications for known interactions.
Cannabidiol in hemp extract may alter the metabolism of other drugs.

Inactive Ingredients:

Ethylglycerin, C13-14 isoparaffin, laureth-7, phenoxyethanol, polyacrylamide, purified water, tetrasodium EDTA, virgin olive oil, vitamin E

Product label

INGREDIENTS AND APPEARANCE

PAIN RELIEF MENTHOL AND HEMP 
hemp extract (cannabis sativa) 1x, menthol (mentholum) tinc. lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73002-342
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	10 mg  in 1 mL
CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D) (CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP - UNII:8X454SZ22D)	CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP	15.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)
OLIVE OIL (UNII: 6UYK2W1W1E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73002-342-02	56 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2020

Labeler - Green Earth Health Inc. (116983264)

Registrant - Green Earth Health Inc. (116983264)