FISICO Arthrozene Pain Cream

Manufacturer
FISICO INC.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:07

Label at a glance#

ProductFISICO Arthrozene Pain Cream
Active ingredientMENTHOL
Label structure7 sections

Dosage and administration

Adults and children two-years of age or 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 Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.00%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

  • For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, consult physician.

Do Not Use 

OTC - DO NOT USE SECTION

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Additional Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Emu Oil, Eucalyptus Globulus Oil, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Magnesium Sulfate, Methylsulfonylmethane (MSM), Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039690menthol 5 % Topical CreamPSN2
1039690menthol 50 MG/ML Topical CreamSCD2
1039690menthol 5 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83204-375-00FISICO Arthrozene Pain Cream96.4 g in 1 TUBECREAM96.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83204-375FISICO ARTHROZENE PAIN CREAM (MENTHOL) CREAM [FISICO INC.]2Current NDC, 1 package rows20231106_d02c4349-78dd-4672-9582-50124ea9f1e1.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83204-37583204-375-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
FISICO Arthrozene Pain CreamMENTHOLFISICO INC.d02c4349-78dd-4672-9582-50124ea9f1e12023-11-06WarningsExact identifier
ndc (package): 83204-375-00
ndc (product): 83204-375
ndc11 (package): 83204037500
spl id: 0976e636-18cd-0818-e063-6294a90adeb8
spl set id: d02c4349-78dd-4672-9582-50124ea9f1e1

Reported adverse events (FAERS/openFDA)#

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