Methyl Salicylate by PHARMACURE, INC. METHYL SALICYLATE patch

Methyl Salicylate by

Drug Labeling and Warnings

Methyl Salicylate by is a Otc medication manufactured, distributed, or labeled by PHARMACURE, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                                                                                     Purpose

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

PURPOSE

Uses

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

strains sprains simple backache arthritis bruises

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 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.

KEEP OUT OF REACH OF CHILDREN

Directions

 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

INGREDIENTS AND APPEARANCE

METHYL SALICYLATE 
methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79643-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
MYRRH (UNII: JC71GJ1F3L)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79643-003-01	2 in 1 BOX	02/17/2023
1		5 in 1 POUCH
1		1000 mg in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/17/2023

Labeler - PHARMACURE LLC (055983858)