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. 0.1% (1mg) HPUS                                       Analgesic

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

PURPOSE

Indication:

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

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 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:

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:

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

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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: 73002-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	1 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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73002-312-02	56 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/19/2019

Labeler - Green Earth Health Inc. (116983264)

Registrant - Green Earth Health Inc. (116983264)

Establishment
Name	Address	ID/FEI	Business Operations
Maitland Labs of Central Florida		080974960	manufacture(73002-312)

Establishment
Name	Address	ID/FEI	Business Operations
Organics Corporation of America DBA Ambix Laboratories		061061164	manufacture(73002-312)