PAIN RELIEF CAFFEINE AND SNAKE VENOM (caffeine (coffeinum) 6x, cobra venom (naja naja) 5x, mocassin venom- a.piscivorus 7x spray

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients                                                                           Purpose

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                 Analgesic
Cobra venom (Naja naja) 5X (0.07mg) HPUS                              Analgesic
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, headache, menstrual cramps periodic neuropathy and sciatica.

KEEP OUT OF REACH OF CHILDREN

Warnings:

Side effects might include headache, nausea, sore throat, allergic rhinitis, gastrointestinal discomfort, itchiness or mild rash.
Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
If symptoms persist or worsen, stop using this product and consult 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.
Keep out of reach of children.

Directions For Use:

Do not use if tamper-proof cover is damaged.
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.

Inactive Ingredients:

Citric acid USP, flavouring, purified water, sodium benzoate NF, sodium phosphate monobasic USP, xylitol NF.

Principal display panel

INGREDIENTS AND APPEARANCE

PAIN RELIEF CAFFEINE AND SNAKE VENOM 
caffeine (coffeinum) 6x, cobra venom (naja naja) 5x, mocassin venom (a.piscivorus) 7x spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73002-111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	6 [hp_X]  in 1 mL
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)	NAJA NAJA VENOM	4 [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)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
XYLITOL (UNII: VCQ006KQ1E)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73002-111-01	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(73002-111)

Establishment
Name	Address	ID/FEI	Business Operations
Organics Corporation of America DBA Ambix Laboratories		061061164	manufacture(73002-111)