Methyl Salicylate 10%
Methyl Salicylate 10% Patch
af2bbcb8-c04c-4f55-84be-2519642f9260
HUMAN OTC DRUG LABEL
Jun 7, 2025
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
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
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
Uses
Temporarily relieves aches & pains of muscles & joints associated with:
- Stains
- Sprains
- Simple Backache
- Arthritis
- Bruises
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients:
Methyl Salicylate 10% (NSAID: nonsteroidal anti-inflammatory drug)
OTC - PURPOSE SECTION
Purpose
External analgesic
WARNINGS SECTION
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
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
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
Questions or comments?
Call 877-227-3137