METHYL SALICYLATE 25% patch

Methyl Salicylate 25% by

Drug Labeling and Warnings

Methyl Salicylate 25% by is a Otc medication manufactured, distributed, or labeled by iON Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts section

Drug Facts

Active Ingredient: Purpose

Methyl Salicylate 25% (NSAID: nonsteroidal anti-inflammatory drug).......... Topical analgesic

Uses

Uses:

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

• Strains
• Sprains
• Simple Backache
• Arthritis
• Bruises

Do not use section

Warning: For external use only.

Stomach bleeding warning: This product contains a 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 a 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 14 or more days
• right before or after heart surgery
• do not bandage tightly

When using this product section

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 section

Stop use and consult 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 breastfeeding section

If pregnant or breastfeeding:

Ask a doctor before use while breastfeeding 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 unbom child or complications during delivery.

Keep out of reach of children section

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.

Directions 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 affected area or intact skin up to 36 hours
• do not use more than 2 patches per day
• do not use for more than 3 days in a row unless prescribed and instructed by a healthcare provider
• the used patch should be removed from the skin when a new one is applied.

Storage and other information section

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

INACTIVE INGREDIENT

Hypoallergenic Acrylic Adhesive

Questions or comments section

Questions or Comments: 833.711.8833 info@ionpharmausa.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

METHYL SALICYLATE 25% 
methyl salicylate 25% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82944-105
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	25 g

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)

Product Characteristics
Color		Score
Shape	SQUARE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82944-105-30	1 in 1 BOX	04/01/2025
1		30 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	04/01/2025

Labeler - iON Pharma, LLC (118739596)