Methyl Salicylate 10% Patch

Manufacturer
ViolaCare, Inc.
Effective date
2025-06-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:02:40

Label at a glance#

ProductMethyl Salicylate 10%
Active ingredientMETHYL SALICYLATE
Label structure10 sections

Indications and uses

Temporarily relieves aches & pains of muscles & joints associated with: Stains Sprains Simple Backache Arthritis Bruises

Dosage and administration

Adults and Children 10 years of age and older: only use one patch at a time clean and dry affected area remove patch from backing film and apply to skin (see illustration) apply 1 patch to the affective area of intact skin up to 24 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

Storage and handling

Store at 20-25°C (66-77°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#

​

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 10% (NSAID: nonsteroidal anti-inflammatory drug)

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves aches & pains of muscles & joints associated with:

  • Stains
  • 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 as NSAID (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product

Do not use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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 heat surgery

Ask a doctor before use if

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If put in mouth, get medical help or contact a Poison Control right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 10 years of age and older:

  • only use one patch at a time
  • clean and dry affected area
  • remove patch from backing film and apply to skin (see illustration)
  • apply 1 patch to the affective area of intact skin up to 24 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

Other information

STORAGE AND HANDLING SECTION

  • Store at 20-25°C (66-77°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

Alpha Tocopherol Acetate, Aluminum Glycinate, Aluminum Hydroxide, Aluminum Sulphate, Borax, Carbomer, Collodial Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone, Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Propylene Glycol, Sodium Polyacrylate, Sorbitol, Sorbitan Monooleate, Tartric Acid & Titanium Dioxide 

Questions or comments?

INACTIVE INGREDIENT SECTION

Call 877-227-3137

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

methyl salicylate jpgmethyl salicylate jpg

NDC 85231-101-15

METHYL SALICYLATE 10%
Topical Analgesic (NSAID)

Pain Relieving Gel Patch

Soothing and Effective Long Lasting Relief

24 Hour Application

15 Patches

3.94 in x 5.5 in EACH

Packaged For:

ViolaCare Inc.

Parsippany, New Jersey, 07054

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053397methyl salicylate 10 % Medicated PatchPSN2
1053397methyl salicylate 0.1 MG/MG Medicated PatchSCD2
1053397methyl salicylate 10 % Medicated PatchSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85231-101-15Methyl Salicylate 10%1 in 1 POUCHPATCH12
85231-101-15Methyl Salicylate 10%15 in 1 BOXPATCH152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85231-101-15EA - Each85231-1016700f871-43c2-479c-8a2a-7e6941c27cfe12025-09-12

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85231-10185231-101-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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 Salicylate 10%METHYL SALICYLATEViolaCare, Inc.af2bbcb8-c04c-4f55-84be-2519642f92602025-06-07WarningsExact identifier
ndc (package): 85231-101-15
ndc (product): 85231-101
ndc11 (package): 85231010115
spl id: 36f75a71-4cab-413e-e063-6394a90a8f55
spl set id: af2bbcb8-c04c-4f55-84be-2519642f9260

Reported adverse events (FAERS/openFDA)#

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