GR ARTHRITIS PAIN RELIEF ROLL-ON 1500 MG- pain relief lotion

GR Arthritis pain relief roll-on 1500 mg by

Drug Labeling and Warnings

GR Arthritis pain relief roll-on 1500 mg by is a Otc medication manufactured, distributed, or labeled by Clarity Labs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This Arthritis Pain Relief lotion has been formulated with camphor and menthol to help with aches and pains, and then added cannabinoids, avocado oil, black cohosh, horsetail, and more to create a truly unique lotion for the wellbeing of muscles and joints.

Active Ingredients

Camphor 4% w/w. Purpose: Topical Analgesic

Menthol 8% w/w. Purpose: Topical Analgesic

Purpose

Topical Analgesic, pain relief lotion

Use

Pain relief lotion to help reduce minor aches and pains of muscles and joints associated with: arthritis, strains, sprains, simple backaches, and bruises.

Do not use

in children

on open skin wounds

WHEN USING

This product is for external use only.

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Do not bandage tightly when applying this product.

Do not apply this product more than 4 times per day.

Stop use and ask a doctor if irritation or rash occurs. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

This product is for external use only.

Rub the affected area accordingly.

Apply to affected area no more than 3 to 4 times daily.

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Bentonite Clay, Carthamus tinctorius (Safflower) Oleosomes, Cimicifuga racemose (Black Cohosh) Root Extract, Equisetum arvense (Horsetail) Extract, Ethylhexylglycerin, Glycerin, Harpagophylum procumbens (Devil's Claw) Root Extract, Hemp Derived (Cannabis sativa) Cannabinoids, Oenothera biennis (Evening Primrose) FlowerExtract, Persea gratissima (Avocado) Oil, Phenoxyethanol, Stellaria media (Chickweed) Herb Extract, Symphytum officinale (Comfrey) Leaf Extract, Water, and Xanthan Gum.

Manufacturing and Distributors information

MANUFACTURED AND DISTRIBUTED BY:

GREEN ROADS OF FLORIDA, LLC
601 FAIRWAY DR, DEERFIELD BEACH, FL 33441

833-462-8922
GREENROADS.COM

WARNINGS

Avoid contact with eyes

Do not bandage tightly

Do not apply to wounds or damaged skin

For external use only

Design and Label of CONTAINER

Tube Label

Package Label Display box (IFC)

IFC Individual Folding Carton

Most outer BOX

Big Container BOX

INGREDIENTS AND APPEARANCE

GR ARTHRITIS PAIN RELIEF ROLL-ON 1500 MG 
pain relief lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78232-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OENOTHERA BIENNIS FLOWERING TOP (UNII: I3Z7321G2F)	0.5 g  in 100 g
EQUISETUM ARVENSE WHOLE (UNII: 73DM367W4P)	0.5 g  in 100 g
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)	0.5 g  in 100 g
WATER (UNII: 059QF0KO0R)	65 g  in 100 g
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)	12.5 g  in 100 g
BLACK COHOSH (UNII: K73E24S6X9)	0.5 g  in 100 g
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.1 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.9 g  in 100 g
AVOCADO OIL (UNII: 6VNO72PFC1)	2 g  in 100 g
CANNABIDIOL (UNII: 19GBJ60SN5)	2 g  in 100 g
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)	0.5 g  in 100 g
BENTONITE (UNII: A3N5ZCN45C)	2.5 g  in 100 g
STELLARIA MEDIA (UNII: 2H03479QVR)	0.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78232-005-03	363.6 in 1 CARTON	04/05/2022
1	NDC: 78232-005-02	90.9 in 1 BOX
1	NDC: 78232-005-01	90.9 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	04/05/2022

Labeler - Clarity Labs LLC (045246080)

Registrant - Clarity Labs LLC (045246080)

Establishment
Name	Address	ID/FEI	Business Operations
Clarity Labs LLC		045246080	manufacture(78232-005)