DRUG FACTS:

Active Ingredient:

Menthol 5.00%

Purpose

Topical Analgesic

Indications:

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

Warnings:

For external use only

When using this product

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

Keep out of reach of children.

If swallowed, consult physician.

Do Not Use

to wounds or damaged skin.
Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

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:

Store at room temperature.

Inactive ingredients:

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:

Label

FISICO ARTHROZENE PAIN CREAM
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83204-375
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETYL ALCOHOL (UNII: 936JST6JCN)
EMU OIL (UNII: 344821WD61)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: Z6GFR7R72Y)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN (UNII: 0N8672707O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83204-375-00	96.4 g in 1 TUBE; Type 0: Not a Combination Product	11/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	11/14/2022

Labeler - FISICO INC. (844676903)

FISICO Arthrozene Pain Cream