fisico arthrozene pain cream

fisico arthrozene pain cream
SPL v2
SPL
SPL Set ID d02c4349-78dd-4672-9582-50124ea9f1e1
Route
topical
Published
Effective Date 2023-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (50 mg)
Inactive Ingredients
aloe vera leaf water arnica montana flower indian frankincense cetostearyl alcohol cetearyl olivate cetyl alcohol emu oil eucalyptus oil glycerin glyceryl caprylate glyceryl monostearate glycyrrhiza glabra helianthus annuus flowering top magnesium sulfate, unspecified form dimethyl sulfone sodium laurylglucosides hydroxypropylsulfonate sorbitan olivate stearic acid xanthan gum corn

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-11-14

Purpose

Topical Analgesic

Description

Menthol 5.00%


Medication Information

Purpose

Topical Analgesic

Description

Menthol 5.00%

Warnings:
  • For external use only
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.
Do Not Use 
  • to wounds or damaged skin.
  • Do not bandage tightly.
Indications:

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

Package Labeling:

Active Ingredient:

Menthol 5.00%

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.

Additional Information:

Store at room temperature.

When Using This Product
  • avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
If Pregnant Or Breast Feeding,
  • contact physician prior to use.
Keep Out of Reach of Children. 
  • If swallowed, consult physician.

Structured Label Content

Purpose

Topical Analgesic

Warnings:
  • For external use only
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.
Do Not Use 
  • to wounds or damaged skin.
  • Do not bandage tightly.
Indications:

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

Package Labeling:

Active Ingredient:

Menthol 5.00%

Inactive Ingredients: (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.

Additional Information:

Store at room temperature.

When Using This Product (When using this product)
  • avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)
  • contact physician prior to use.
Keep Out of Reach of Children.  (Keep out of reach of children. )
  • If swallowed, consult physician.

Advanced Ingredient Data


Raw Label Data

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