FDA Label for Methyl Salicylate 40 Percent

View Indications, Usage & Precautions

Methyl Salicylate 40 Percent Product Label

The following document was submitted to the FDA by the labeler of this product Alexso, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Methyl Salicylate 40%


Purpose



Topical analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, strains, bruises, and sprains.


Warnings



​For external use only.


When Using This Product



  • Avoid contact with the eyes
  • Do not use in large quantities, particularly over raw surfaces or blistered areas
  • Do not apply to wounds or damaged skin
  • Do not bandage

Stop Use And Ask A Doctor If



  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep Out Of Reach Of Children.



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


Directions:



Adults and children 2 years and older: apply externally to the affected area up to 3 to 4 times a day

Children under 2 years of age: consult a doctor


Other Information



  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Inactive Ingredients



Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

Methyl Salicylate 40% Cream

NDC: 50488-6040-6

60 gram

Manufactured for:
Alexso, Inc
2317 Cotner Ave
Los Angeles, CA 90064


Principal Display Panel



NDC 50488-6040-6
Methyl Salicylate 40% Cream
Net Wt. 2 oz. 60 g

Rev 10/23


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