MedPath

Methyl Salicylate 10%

Methyl Salicylate 10% Patch

Approved
Approval ID

af2bbcb8-c04c-4f55-84be-2519642f9260

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 7, 2025

Manufacturers
FDA

ViolaCare, Inc.

DUNS: 119452160

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Methyl Salicylate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85231-101
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Methyl Salicylate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 7, 2025
FDA Product Classification

INGREDIENTS (15)

ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
CARBOMER 940Inactive
Code: 4Q93RCW27E
Classification: IACT
DMDM HYDANTOINInactive
Code: BYR0546TOW
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
POLYACRYLIC ACID (250000 MW)Inactive
Code: 9G2MAD7J6W
Classification: IACT
POLYVINYL ALCOHOL (100000 MW)Inactive
Code: 949E52Z6MY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM POLYACRYLATE (8000 MW)Inactive
Code: 285CYO341L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SORBITAN MONOOLEATEInactive
Code: 06XEA2VD56
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHYL SALICYLATEActive
Quantity: 10 g in 100 g
Code: LAV5U5022Y
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/8/2025

PRINCIPAL DISPLAY PANEL

methyl 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

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/1/2025

Uses

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

  • Stains
  • Sprains
  • Simple Backache
  • Arthritis
  • Bruises

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/8/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/1/2025

Active ingredients:

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/1/2025

Purpose

External analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/1/2025

Warnings

​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

  • 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

  • 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

  • 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

  • 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 right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/1/2025

Directions

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 SECTION

LOINC: 44425-7Updated: 5/1/2025

Other information

  • 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 INGREDIENT SECTION

LOINC: 51727-6Updated: 5/2/2025

Questions or comments?

Call 877-227-3137

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Methyl Salicylate 10% - FDA Drug Approval Details