Methyl Salicylate 25 Percent Cream
FDA Label NDC 50488-1016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alexso, Inc for the product Methyl Salicylate 25 Percent (NDC 50488-1016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Methyl Salicylate 25%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, 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 olderapply externally to the affected area up to 3 to 4 times a day
 children under 2 years ask 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

Aqua (Deionized Water), Arnica Montana Flower Extract, Indian Frankincense, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Monostearate, Cetostearyl Alcohol, Aloe Vera Leaf, C13-14 Isoparaffin, Isostearyl Palmitate, Trolamine, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid.

Methyl Salicylate 25% Pump Bottle Cream

NDC: 50488-1016-5

50 mL

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

Tel: 888.495.6078

Principal Display Panel

NDC 50488-1016-5
Methyl Salicylate 25% Pump Bottle Cream
50 mL

Rev 05/24

Ndc 50488-1016-5methyl Salicylate 25% Pump Bottle Cream50 mLrev 05/24 (Methyl Salicylate 25 Percent Pump Cream 01)

Ndc 50488-1016-5methyl Salicylate 25% Pump Bottle Cream50 mLrev 05/24 (Methyl Salicylate 25 Percent Pump Cream 01)

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