PAIN RELIEF CAFFEINE AND HEMP (caffeine (coffeinum) 6x, hemp extract- cannabis sativa 2x spray

PAIN RELIEF CAFFEINE AND HEMP by

Drug Labeling and Warnings

PAIN RELIEF CAFFEINE AND HEMP by is a Homeopathic medication manufactured, distributed, or labeled by Green Earth Health Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients                                                                                            Purpose

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                                 Analgesic
Hemp extract (Cannabis sativa) 2X (11.3 mg) HPUS                                    Anti-inflammatory

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

PURPOSE

Indication:

Temporarily relieves pain associated with cystitis, headaches, neuropathy, and sciatica.

KEEP OUT OF REACH OF CHILDREN

Warnings:

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 or 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 tamperproof 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 CAFFEINE AND HEMP 
caffeine (coffeinum) 6x, hemp extract (cannabis sativa) 2x spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73002-321
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE CITRATE	6 [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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)
TEA LEAF (UNII: GH42T47V24)
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: 73002-321-01	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)

Establishment
Name	Address	ID/FEI	Business Operations
Maitland Labs of Central Florida		080974960	manufacture(73002-321)

Establishment
Name	Address	ID/FEI	Business Operations
Organics Corporation of America DBA Ambix Laboratories		061061164	manufacture(73002-321)