Methyl Salicylate 25% Cream
FDA Label NDC 80425-0544

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Of Tennessee, Llc for the product Methyl Salicylate 25% Cream (NDC 80425-0544). 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 the 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%

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 larger 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 The 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 yearsask 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.

* Please review the disclaimer below.