PAIN RELIEF SNAKE VENOM AND HEMP (cobra venom (naja naja) 5x, hemp extract (cannabis sativa) 2x, mocassin venom- a.piscivorus 7x spray

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients                                                                                  Purpose

Cobra venom (Naja naja) 5X (0.07mg) HPUS                                        Analgesic
Hemp extract (Cannabis sativa) 2X (11.3mg) HPUS                              Anti-inflammatory
Mocassin venom (A.piscivorus) 7X (0.007mg) HPUS                            Analgesic

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

PURPOSE

Indication:

Temporarily relieves pain associated with back and neck pain, cystitis, headache, menstrual cramps, and periodic neuralgia.

KEEP OUT OF REACH OF CHILDREN

Warnings:

Side effects might include headache, nausea, sore throat, allergic rhinitis, gastrointestinal discomfort, itchiness or mild rash.
If symptoms persist or worsen, stop using this product and consult a physician.
Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.
If pregnant or breastfeeding ask a health professional before use.
If diagnosed with psychiatric or mood disorder, seek medical advice before use.
Keep out of reach of children.

Directions For Use:

Do not use if tamper proof cover is missing.
Press down 4 times to prime the pump.
Spray 2 times directly into the mouth or under the tongue.
Start using 3 times per day. Use as needed thereafter to relieve discomfort.
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.
Cannabidiol in hemp extract may alter the metabolism of other drugs.

Inactive Ingredients:

Citric acid USP, flavoring, glycerin USP, potassium sorbate USP, purified water, sodium benzoate NF, vitamin C USP, xanthan gum NF.

Principal display panel

INGREDIENTS AND APPEARANCE

PAIN RELIEF SNAKE VENOM AND HEMP 
cobra venom (naja naja) 5x, hemp extract (cannabis sativa) 2x, mocassin venom (a.piscivorus) 7x spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73002-211
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)	NAJA NAJA VENOM	4 [hp_X]  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	2 [hp_X]  in 1 mL
AGKISTRODON PISCIVORUS VENOM (UNII: X9V1Q8U150) (AGKISTRODON PISCIVORUS VENOM - UNII:X9V1Q8U150)	AGKISTRODON PISCIVORUS VENOM	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)
TEA LEAF (UNII: GH42T47V24)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73002-211-01	28 mL in 1 BOTTLE, SPRAY; 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(73002-211)

Establishment
Name	Address	ID/FEI	Business Operations
Organics Corporation of America DBA Ambix Laboratories		061061164	manufacture(73002-211)