MUSCLE AND JOINT PAIN RELIEF GR ISOLATE 350 MG- pain relief cream

Muscle and Joint pain relief GR Isolate 350 mg by

Drug Labeling and Warnings

Muscle and Joint pain relief GR Isolate 350 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 Pain Relief Cream has been formulated with methyl salicylate and menthol to help with aches and pains, and then added CBD, rosemary oil, vitamin E and more to create a truly unique cream for the wellbeing of muscles and joints.

Active Ingredients

Methyl Salicylate 10% w/w. Purpose: Topical Analgesic

Menthol 4% w/w. Purpose: Topical Analgesic

Purpose

Topical Analgesic, pain relief cream

Use

Pain relief cream 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.

Place enough on one hand to cover the affected area and rub the 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, Carthamus tinctorius Oleosomes, Cucumis sativus Fruit Extract, Ethylhexylglycerin, Glycerin, Hemp Derived Cannabinoid Extract, Lavandula angustifolia Oil, Persea gratissima Oil, Phenoxyethanol, Rosmarinus o­fficinalis Oil, Tocopherol, Xanthan Gum, Water.

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 BOX

Tube Label

Package Label Outer Box IFC

IFC Individual Folding Carton

Most outer BOX

Big Container BOX

INGREDIENTS AND APPEARANCE

MUSCLE AND JOINT PAIN RELIEF GR ISOLATE 350 MG 
pain relief cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78232-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)	0.83 g  in 100 g
CUCUMBER (UNII: YY7C30VXJT)	0.83 g  in 100 g
WATER (UNII: 059QF0KO0R)	57.77 g  in 100 g
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)	12.5 g  in 100 g
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)	0.83 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)	5 g  in 100 g
CANNABIDIOL (UNII: 19GBJ60SN5)	1.41 g  in 100 g
BENTONITE (UNII: A3N5ZCN45C)	5 g  in 100 g
CHAMOMILE (UNII: FGL3685T2X)	0.83 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78232-003-03	120 in 1 CARTON	04/23/2021
1	NDC: 78232-003-02	30 in 1 BOX
1	NDC: 78232-003-01	30 g in 1 TUBE; 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	04/23/2021

Labeler - Clarity Labs LLC (045246080)

Registrant - Clarity Labs LLC (045246080)

Establishment
Name	Address	ID/FEI	Business Operations
Clarity Labs LLC		045246080	manufacture(78232-003)