Methyl Salicylate Patch
FDA Label NDC 50488-2010

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 (NDC 50488-2010). 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 ​, purpose, uses, warnings, keep out of reach of children., when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Purpose

Methyl Salicylate 10% …………………………..…………………….….…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. Use only as directed or as directed by a health care professional.

Read all warnings and directions before use.

Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

Do not use:

• On wounds, cuts, damaged or infected skin

• On eyes, mouth, genitals, or any other mucous membranes

Keep Out Of Reach Of Children.

Consult physician for children under 18.​

When Using This Product

  • Avoid contact with the eyes
  • You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
  • Avoid contact with the eyes, lips, nose and mucous membranes
  • Do not tightly wrap or bandage the treated area
  • Do not apply heat to the treated area immediately before or after use

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

Directions

Adults and children 18 years of age and older:

Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.

- Clean and dry the affected area.

- Open pouch and remove one patch.

- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.

- Wash hands with soap and water after handling the patches.

- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.

- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 18 years: Ask a physician

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

Polysorbate 80, Glycerin, Sodium Cellulose Glycolate, Sodium Polyacrylate, Vitamin E, EDTA Disodium Salt, Kaolin, Water, Methylparaben

Methyl Salicylate 10% Patch 

NDC: 50488-2010-1

10 Patches

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

Principal Display Panel

Methyl Salicylate 10% Patch
Topical Analgesic
NDC 50488-2010-1
10 Patches

Principal Display Panelmethyl Salicylate 10% Patchtopical Analgesicndc 50488-2010-110 Patches (Methyl Salicylate Patch 01)

Principal Display Panelmethyl Salicylate 10% Patchtopical Analgesicndc 50488-2010-110 Patches (Methyl Salicylate Patch 01)

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