FDA.reportPublic FDA data

ZENSEZONE Arthmed Temporary Pain Relief Cream

Manufacturer
ZENSEZONE LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:14

Label at a glance#

ProductZENSEZONE Arthmed Temporary Pain Relief Cream
Active ingredientCAPSAICIN, MENTHOL, METHYL SALICYLATE
Label structure7 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.

Dosage and administration

Adults and children two-years of age an older: Apply to affected area not more than three to four times daily. Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Menthol 10%

Methyl Salicylate 15%

Purpose:

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.

Warnings:

WARNINGS SECTION

not intended for ingestion. For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove 
  • Do not bandage tightly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur agin within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children two-years of age an older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate') Extract, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Other information:

SPL UNCLASSIFIED SECTION

  • Potect the product in this container from excessive heat and direct sun.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283270capsaicin 0.025 % / menthol 10 % / methyl salicylate 15 % Topical CreamPSN2
283270capsaicin 0.25 MG/ML / menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD2
283270capsaicin 0.025 % / menthol 10 % / methyl salicylate 15 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82319-240-00ZENSEZONE Arthmed Temporary Pain Relief Cream118 mL in 1 BOTTLECREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82319-240ZENSEZONE ARTHMED TEMPORARY PAIN RELIEF CREAM (CAPSAICIN, MENTHOL, METHYL SALICYLATE) CREAM [ZENSEZONE LLC]2Current NDC, Legacy NDC, 1 package rows20231112_c5778f22-c411-4bd7-b2af-45e3fee15fd2.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82319-24082319-240-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CETYL ALCOHOL936JST6JCNIACT
EMU OIL344821WD61IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
CORN0N8672707OIACT
CAPSAICINS07O44R1ZMACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
ZENSEZONE Arthmed Temporary Pain Relief CreamCAPSAICIN, MENTHOL, METHYL SALICYLATEZENSEZONE LLCc5778f22-c411-4bd7-b2af-45e3fee15fd22023-11-11WarningsExact identifier
ndc (package): 82319-240-00
ndc (product): 82319-240
ndc11 (package): 82319024000
spl id: 09e32c60-2b41-0226-e063-6294a90a6a2f
spl set id: c5778f22-c411-4bd7-b2af-45e3fee15fd2

Reported adverse events (FAERS/openFDA)#

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