Methyl Salicylate

Manufacturer
PHARMACURE LLC
Effective date
2025-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:26

Label at a glance#

ProductMethyl Salicylate
Active ingredientMETHYL SALICYLATE
Label structure7 sections

Indications and uses

Temporarily relieves mild to moderate aches & pains of muscles & joints associated with: • strains • sprains • simple backache • arthritis • bruises

Dosage and administration

 Adults 18 years and older: • Clean and dry affected area • Only use one patch at a time • Remove patch from backing film and apply to skin • Apply one patch to the affected area and leave in place for up to 8 to 12 hours • If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours • Do not use more than 2 patches per day • Do not use for more than 3 days in a row • Th...

Storage and handling

• Store at 20-25°C (68-77°F) • Avoid storing product in direct sunlight •Protect product from excessive moisture •Some individuals may not experience pain relief until several hours after applying the patch

Label contents#

Full prescribing information#

Active Ingredient                                                                                     Purpose

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25% (NSAID: nonsteroidal anti-inflammatory drug)            Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves mild to moderate aches & pains of muscles & joints associated with:

• strains • sprains • simple backache • arthritis • bruises

Warnings

WARNINGS SECTION

For external use only
Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding.
The chance is small but higher if you:

• are age 60 or older • have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed

Do not use

• on the face or rashes • on wounds or damaged skin • if allergic to aspirin or other NSAIDs
• with a heating pad • when sweating (such as from exercise or heat)
• any patch from a pouch that has been open for 14 or more days • right before or after heart surgery

Ask a doctor before use if
• you are allergic to topical products • the stomach bleeding warning applies to you
• you have high blood pressure, heart disease, or kidney disease • you are taking a diuretic

When using this product

• wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if
• stomach pain or upset gets worse or lasts • you feel faint, vomit blood, or have bloody or black stools
These are signs of stomach bleeding. • rash, itching or skin irritation develops
• condition worsens
• symptoms last for more than 3 days • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a doctor before use while breast-feeding and during the first 6 months of pregnancy. Do not use during the last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Directions

DOSAGE & ADMINISTRATION SECTION

 Adults 18 years and older:

•Clean and dry affected area • Only use one patch at a time
• Remove patch from backing film and apply to skin
• Apply one patch to the affected area and leave in place for up to 8 to 12 hours
• If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours

• Do not use more than 2 patches per day • Do not use for more than 3 days in a row
• The used patch should be removed from the skin when a new one is applied
• Children under 18 years of age: do not use: this product has not been shown to work in children

Other information

STORAGE AND HANDLING SECTION

• Store at 20-25°C (68-77°F) • Avoid storing product in direct sunlight
•Protect product from excessive moisture
•Some individuals may not experience pain relief until several hours after applying the patch

Inactive ingredients

INACTIVE INGREDIENT SECTION

Adhesive, myrrh gum, zinc oxide.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2704558methyl salicylate 25 % Medicated PatchPSN1
2704558methyl salicylate 0.25 MG/MG Medicated PatchSCD1
2704558methyl salicylate 25 % Medicated PatchSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79643-010-01Methyl Salicylate10 in 1 BOXPATCH101
79643-010-01Methyl Salicylate8 g in 1 PATCHPATCH81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79643-010METHYL SALICYLATE PATCH [PHARMACURE LLC]1Current NDC, 2 package rows20250207_2c32cfed-2022-4e7c-ae9c-ba22dbb560af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79643-010-01EA - Each79643-0106a5a3222-d8f3-4160-beda-cc779746e4fa12025-03-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79643-01079643-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MYRRHJC71GJ1F3LIACT
ZINC OXIDESOI2LOH54ZIACT
METHYL SALICYLATELAV5U5022YACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC2c32cfed-2022-4e7c-ae9c-ba22dbb560af2025-02-04WarningsExact identifier
ndc (package): 79643-010-01
ndc (product): 79643-010
ndc11 (package): 79643001001
spl id: 2d52c9bb-c390-800d-e063-6394a90af8d3
spl set id: 2c32cfed-2022-4e7c-ae9c-ba22dbb560af

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.