PAIN RELIEF MENTHOL AND SNAKE VENOM (cobra venom (naja naja) 2x, menthol (mentholum) tinc, mocassin venom- a.piscivorus 4x gel

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients                                                                           Purpose

Cobra venom (Naja naja) 2X 1% (0.1mg)                                         HPUS Analgesic
Menthol (Mentholum) Tinc. 0.1% (1mg)                                           HPUS Analgesic
Mocassin venom (A.piscivorus) 4X 1%(0.001mg)                             HPUS Analgesic

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

PURPOSE

Indication:

Temporarily relieves pain associated with arthritis, backache, bruises, neck pain and periodic neuralgia.

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.

Inactive Ingredients:

Benzalkonium chloride NF, glycerol USP, hypromellose USP, propylene glycol NF, purified water, sodium chloride USP.

Principal display panel

INGREDIENTS AND APPEARANCE

PAIN RELIEF MENTHOL AND SNAKE VENOM 
cobra venom (naja naja) 2x, menthol (mentholum) tinc, mocassin venom (a.piscivorus) 4x gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73002-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)	NAJA NAJA VENOM	0.1 mg  in 1 mL
MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W)	MENTHOL, (+)-	1 mg  in 1 mL
AGKISTRODON PISCIVORUS VENOM (UNII: X9V1Q8U150) (AGKISTRODON PISCIVORUS VENOM - UNII:X9V1Q8U150)	AGKISTRODON PISCIVORUS VENOM	0.001 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
1,2-PROPANEDIOL, 1-BENZOATE (UNII: K4K90ZQ89N)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73002-122-02	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(73002-122)

Establishment
Name	Address	ID/FEI	Business Operations
Organics Corporation of America DBA Ambix Laboratories		061061164	manufacture(73002-122)