METHYL SALICYLATE- methyl salicylate patch 

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


Active Ingredient                                                                                     Purpose

Methyl Salicylate 10% (NSAID: Nonsteroidal anti-inflammatory drug)            Topical Analgesic


Temporarily relieves mild to moderate aches & pains of muscles & joints associated with:

• strains • sprains • simple backache • arthritis • bruises


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 an NSAID (aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed

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 heart surgery

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

When using this product

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

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


 Adults 18 years and older:

Clean and dry affected area • Only use one patch at a time
• Remove patch from backing film and apply to skin
• Apply one patch to the affected area and leave in place for up to 8 to 12 hours
• If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 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
• Children under 18 years of age: do not use: this product has not been shown to work in children

Inactive ingredients

Adhesive, myrrh gum, zinc oxide.

Other information

• Store at 20-25°C (68-77°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

Product label

image description

methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79643-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79643-003-012 in 1 BOX02/17/2023
15 in 1 POUCH
11000 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/17/2023
Labeler - PHARMACURE, INC. (055983858)

Revised: 3/2023
Document Id: f6c901e2-a565-df63-e053-6294a90a7aaa
Set id: 66b13044-69d2-4559-9e65-8a4c601c077a
Version: 2
Effective Time: 20230313