MUSCLE AND JOINT PAIN RELIEF GR ISOLATE 750 MG- pain relief cream 
Clarity Labs LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Muscle and Joint pain relief Mighty 750 mg 1 Oz/30 g

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

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 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.

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

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

Tube Label

Package Label Outer Box IFC

IFC Individual Folding Carton

IFC Label

Most outer BOX

Big Container BOX

Most outer box

MUSCLE AND JOINT PAIN RELIEF GR ISOLATE 750 MG 
pain relief cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78232-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CUCUMBER (UNII: YY7C30VXJT) 0.83 g  in 100 g
WATER (UNII: 059QF0KO0R) 56.16 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) 3.02 g  in 100 g
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.83 g  in 100 g
BENTONITE (UNII: A3N5ZCN45C) 5 g  in 100 g
CHAMOMILE (UNII: FGL3685T2X) 0.83 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78232-002-03120 in 1 CARTON02/01/2021
1NDC:78232-002-0230 in 1 BOX
1NDC:78232-002-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/01/2021
Labeler - Clarity Labs LLC (045246080)
Registrant - Clarity Labs LLC (045246080)
Establishment
NameAddressID/FEIBusiness Operations
Clarity Labs LLC045246080manufacture(78232-002)

Revised: 11/2021
Document Id: d1e59744-6211-ba2c-e053-2a95a90a2996
Set id: b8f35f14-ce00-45f7-e053-2995a90a4c6d
Version: 5
Effective Time: 20211128
 
Clarity Labs LLC