Indications and 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.
Methyl Salicylate Patch
- Manufacturer
- Alexso, Inc
- Effective date
- 2024-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:41:04
Label at a glance#
ProductMethyl Salicylate
Active ingredientMETHYL SALICYLATE
Label structure8 sections
Dosage and administration
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...
Storage and handling
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.
Label contents#
Full prescribing information#
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
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50488-2010-1 | Methyl Salicylate | 2 in 1 BOX | PATCH | 2 | 2 | |
| 50488-2010-1 | Methyl Salicylate | 5 in 1 POUCH | PATCH | 5 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50488-2010 | METHYL SALICYLATE PATCH [ALEXSO, INC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241208_bac67f94-8627-47ff-a736-37feab77330a.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50488-2010-1 | EA - Each | 50488-2010 | 29923153-67b9-43b6-a527-3585fb9a7b25 | 1 | 2021-05-05 |
Products#
Every source-derived product name is available through these pages.
- Methyl Salicylate
- SALICYLIC ACID
- POLYSORBATE 80
- GLYCERIN
- CARBOXYMETHYLCELLULOSE SODIUM
- .ALPHA.-TOCOPHEROL
- EDETATE DISODIUM
- KAOLIN
- WATER
- METHYLPARABEN
- SODIUM POLYACRYLATE (8000 MW)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50488-2010 | 50488-2010-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| .ALPHA.-TOCOPHEROL | H4N855PNZ1 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| KAOLIN | 24H4NWX5CO | IACT |
| WATER | 059QF0KO0R | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| SODIUM POLYACRYLATE (8000 MW) | 285CYO341L | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methyl Salicylate | METHYL SALICYLATE | Alexso, Inc | bac67f94-8627-47ff-a736-37feab77330a | 2024-12-09 | Warnings | 50488-2010-1 50488-2010 50488201001 e7bb5525-446b-42ae-b4cd-c3c25a2521ec bac67f94-8627-47ff-a736-37feab77330a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.