Methyl Salicylate Patch

Methyl Salicylate Patch
SPL v2
SPL
SPL Set ID bac67f94-8627-47ff-a736-37feab77330a
Route
TOPICAL
Published
Effective Date 2024-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Polysorbate 80 Glycerin Carboxymethylcellulose Sodium .alpha.-tocopherol Edetate Disodium Kaolin Water Methylparaben Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-11

Description

Drug Facts

Purpose

Methyl Salicylate 10% …………………………..…………………….….…Topical analgesic


Medication Information

Purpose

Methyl Salicylate 10% …………………………..…………………….….…Topical analgesic

Description

Drug Facts

Drug Facts

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

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 Patch es

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

Principal Display Panel

Methyl Salicylate 10% Patch

Topical Analgesic

NDC 50488-2010-1

10 Patches

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
Keep Out of Reach of Children.

Consult physician for children under 18.


Structured Label Content

Drug Facts

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.

Purpose

Methyl Salicylate 10% …………………………..…………………….….…Topical analgesic

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

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 (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 (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 Patch es

Manufactured for:

Alexso, Inc

Los Angeles, CA 90064

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Methyl Salicylate 10% Patch

Topical Analgesic

NDC 50488-2010-1

10 Patches

When Using This Product (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 (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. (Keep out of reach of children.)

Consult physician for children under 18.


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