Methyl Salicylate 10% Patch

Methyl Salicylate 10% Patch
SPL v2
SPL
SPL Set ID af2bbcb8-c04c-4f55-84be-2519642f9260
Route
TOPICAL
Published
Effective Date 2025-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Alpha-tocopherol Acetate Aluminum Hydroxide Carbomer 940 Dmdm Hydantoin Glycerin Kaolin Polyacrylic Acid (250000 Mw) Polyvinyl Alcohol (100000 Mw) Water Sodium Polyacrylate (8000 Mw) Sorbitol Sorbitan Monooleate Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01

Description

Drug Facts

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Drug Facts

Drug Facts

Uses

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

  • Stains
  • Sprains
  • Simple Backache
  • Arthritis
  • Bruises
Section 50565-1

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.

Section 53414-9

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.

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
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
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
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
Active Ingredients:

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

Inactive Ingredients

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?

Call 877-227-3137

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

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.
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

Structured Label Content

Drug Facts

Uses

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

  • Stains
  • Sprains
  • Simple Backache
  • Arthritis
  • Bruises
Section 50565-1 (50565-1)

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.

Section 53414-9 (53414-9)

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.

Purpose

External analgesic

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
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
Do Not Use (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
Other Information (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
Active Ingredients: (Active ingredients:)

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

Inactive Ingredients (Inactive ingredients)

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? (Questions or comments?)

Call 877-227-3137

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

When Using This Product (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 (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.
Ask A Doctor Before Use If (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

Advanced Ingredient Data


Raw Label Data

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