JOY SKIN & BODY Premium PAIN RELIEVING CREAM

Manufacturer
Joy Organics Llc
Effective date
2021-03-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:02

Label at a glance#

ProductJOY SKIN AND BODY Premium PAIN RELIEVING
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Dosage and administration

• adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. • children under 2 years of age: consult a doctor.

Storage and handling

• protect this product from excessive heat and direct sun. • store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of the muscles and joints associated with

• arthritis • simple backache • sprains • strains • bruises

Warnings

WARNINGS SECTION

Flammable: Keep away from fire or flame

For external use only.

Do not use

• on wounds or damaged skin.

When using this product

• avoid contact with the eyes. If contact occurs, rinse with water to remove

• do not bandage tightly

Stop use and ask a doctor if

• condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

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

• adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

• children under 2 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

• protect this product from excessive heat and direct sun.

• store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Calcium Gluconate, Camphor(Cinnamomum camphora) Oil (0.5%), Cetearyl Glucoside, Cetyl Alcohol, Glucono delta-lactone, Hemp (Cannabis sativa) Extract, Organic Aloe Vera Leaf Juice (0.02%), Organic Glycerin (3%), Organic Lavender(Lavandula angustifolia) Oil (0.1%), Organic Olive(Olea europaea) Oil (10%), Organic Peppermint(Mentha piperita) Oil (0.1%), Organic Rosemary(Rosmarinus officinalis) Oil (0.1%), Organic Sweet Marjoram(Origanum majorana) Oil (0.1%), Organic Wintergreen(Gaultheria procumbens) Oil (0.1%), Potassium Sorbate, Safflower (Carthamus tinctorius) Oleosomes Extract, Sodium Benzoate, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopherol, Water(Aqua), Xanthan Gum.

Questions? +1-833-569-7223

OTC - QUESTIONS SECTION

You may also report serious side effects to this phone number.

Mon - Fri: 9 AM to 5 PM

SPL UNCLASSIFIED SECTION

4% Cooling Menthol for Pain Relief

Cool Menthol

Includes Hemp Extract, Rosemary & Lavender Oil

BROAD SPECTRUM

NON GMO

0.0% THC

USA HEMP

PREMIUM GRADE

Joy's cooling Menthol Pain Relieving Cream combines premium ingredients with efficacious amounts of Menthol to reduce pain and alleviate muscle and joint aches.

This unique formula with Menthol also includes 400mg of CBD oil and a variety of other natural ingredients including, olive oil, rosemary oil, and lavender oils for soothing and powerful results.

OUR PROCESS

Each ingredient in this formula is meticulously sourced for both purity and quality.

LAB RESULTS

Every batch of our products is rigorously tested by an ISO-certified lab for heavy metals, pesticides, molds, CBD and THC.

Manufactured for
Joy Organics, LLC

5042 Technology Pkwy.
Suite 500,
Fort Collins, CO 80528

JoyOrganics.com

Scan QR code or visit JoyOrganics.com/labs to view the lab results.

Live your BEST LIFE

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80977-101-042023-01-30C16284748780-1f386c649-bff9-0266-e053-dadaa90a7c1aJOY SKIN & BODY Premium PAIN RELIEVING CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80977-101-04JOY SKIN AND BODY Premium PAIN RELIEVING1 in 1 CARTONCREAM11
80977-101-04JOY SKIN AND BODY Premium PAIN RELIEVING118 mL in 1 BOTTLECREAM1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80977-101JOY SKIN AND BODY PREMIUM PAIN RELIEVING (MENTHOL) CREAM [JOY ORGANICS LLC]1Legacy NDC, 2 package rows20210319_627edb87-63a1-4be2-860d-07514e27d7ad.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80977-10180977-101-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
d93b9e18-b3a1-4b72-b1fa-48932a2d9b49627edb87-63a1-4be2-860d-07514e27d7ad2021-03-10WarningsExact identifier
spl id: d93b9e18-b3a1-4b72-b1fa-48932a2d9b49
spl set id: 627edb87-63a1-4be2-860d-07514e27d7ad

Reported adverse events (FAERS/openFDA)#

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