Methyl Salicylate 10%

Methyl Salicylate 10%
SPL v1
SPL
SPL Set ID 100844d0-e97f-4494-aa21-21f505223212
Route
TOPICAL
Published
Effective Date 2025-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Carbomer 940 Glycerin Carboxymethylcellulose Sodium, Unspecified Sodium Polyacrylate (8000 Mw) .alpha.-tocopherol Kaolin Water Sorbitol Tartaric Acid Titanium Dioxide Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Active Ingredient                                                                                                         Purpose Methyl Salicylate 10% …………………………..…………………….….…Topical analgesic


Medication Information

Warnings and Precautions

Warnings (​For external use only)

Do not use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Indications and Usage

Uses For temporary relief of pain

Description

Active Ingredient                                                                                                         Purpose Methyl Salicylate 10% …………………………..…………………….….…Topical analgesic

Section 50565-1

Keep out of reach of children.​ If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1

Section 55106-9

Active Ingredient                                                                                                         Purpose

Methyl Salicylate 10% …………………………..…………………….….…Topical analgesic

Directions

Adult and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily

  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Drug Facts

Other Information

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients

CARBOMER 940, Glycerine, Sodium Cellulose Glycolate, Sodium polyacrylate, Vitamin E, Kaolin, Water, SORBITOL, TARTARIC ACID, TITANIUM DIOXIDE, PHENOXYETHONOL.

Principal Display Panel

NDC: 82461-414-10

Medcore LLC

Methyl Salicylate 10%

Pain Relieving Hydrogel Technology

Contains:

10 Patches

Manufactured for: Medcore LLC 3048 Valley Rd Basking Ridge, NJ 07920

Store in a dry, cool place. For Comments or Questions, call 908-280-2269

When Using This Product
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • condition worsen

  • symptoms persist for more than 7 days

  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,​ ask a health professional before use.


Structured Label Content

Indications and Usage (34067-9)

Uses For temporary relief of pain

Warnings and Precautions (34071-1)

Warnings (​For external use only)

Do not use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Section 50565-1 (50565-1)

Keep out of reach of children.​ If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Active Ingredient                                                                                                         Purpose

Methyl Salicylate 10% …………………………..…………………….….…Topical analgesic

Directions

Adult and children 12 years of age and over:

  • clean and dry affected area
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily

  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Drug Facts

Other Information (Other information)

Store at room temperature 15°-30°C (59°-86°F)

Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients (Inactive ingredients)

CARBOMER 940, Glycerine, Sodium Cellulose Glycolate, Sodium polyacrylate, Vitamin E, Kaolin, Water, SORBITOL, TARTARIC ACID, TITANIUM DIOXIDE, PHENOXYETHONOL.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC: 82461-414-10

Medcore LLC

Methyl Salicylate 10%

Pain Relieving Hydrogel Technology

Contains:

10 Patches

Manufactured for: Medcore LLC 3048 Valley Rd Basking Ridge, NJ 07920

Store in a dry, cool place. For Comments or Questions, call 908-280-2269

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • condition worsen

  • symptoms persist for more than 7 days

  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,​ ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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