Muscle and Joint pain relief GR Isolate 350 mg

Manufacturer
Clarity Labs LLC
Effective date
2021-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:10

Label at a glance#

ProductMuscle and Joint pain relief GR Isolate 350 mg
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure16 sections

Dosage and administration

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.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

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

OTC - ACTIVE INGREDIENT SECTION

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

Menthol 4% w/w. Purpose: Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic, pain relief cream

Use

INDICATIONS & USAGE SECTION

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

OTC - DO NOT USE SECTION

in children

on open skin wounds

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

MANUFACTURED AND DISTRIBUTED BY:

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

833-462-8922
GREENROADS.COM

WARNINGS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label

350 tube label350 tube label

Package Label Outer Box IFC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IFC Individual Folding Carton

350 IFC350 IFC

Most outer BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Big Container BOX

350 most outer box350 most outer box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78232-003-032023-01-30C16284748780-1f386c64a-011d-0266-e053-dadaa90a7c1aMuscle and Joint pain relief Moderate 350 mg 1 Oz/30 g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78232-003-01Muscle and Joint pain relief GR Isolate 350 mg30 g in 1 TUBECREAM303
78232-003-02Muscle and Joint pain relief GR Isolate 350 mg30 in 1 BOXCREAM303
78232-003-03Muscle and Joint pain relief GR Isolate 350 mg120 in 1 CARTONCREAM1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78232-003MUSCLE AND JOINT PAIN RELIEF GR ISOLATE 350 MG (PAIN RELIEF) CREAM [CLARITY LABS LLC]3Legacy NDC, 3 package rows20211130_c092fab3-9b0e-ea02-e053-2a95a90acc76.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78232-00378232-003-01, 78232-003-02, 78232-003-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d1e593d8-197c-083d-e053-2995a90a4345c092fab3-9b0e-ea02-e053-2a95a90acc762021-11-28WarningsExact identifier
spl id: d1e593d8-197c-083d-e053-2995a90a4345
spl set id: c092fab3-9b0e-ea02-e053-2a95a90acc76

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.