METHYL SALICYLATE 10%- methyl salicylate patch

Methyl Salicylate 10% by

Drug Labeling and Warnings

Methyl Salicylate 10% by is a Otc medication manufactured, distributed, or labeled by ION PHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients:

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

Purpose

Topical analgesic

Uses

Temporarily relieves 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 as 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 for 14 or more days
• right before or after heat surgery

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

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

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 36 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

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 ingredients

Hypoallergenic Acrylic Adhesive

Questions or comments?

833.711.8833

• info@ionpharmausa.com

PRINCIPAL DISPLAY PANEL

NDC: 82944-101-10

METHYL SALICYLATE 10%
Topical Analgesic (NSAID)

TOPICAL PAIN PATCH

For Temporary Pain Relief

Flexible Patch Innovation

Soothing and Effective
Long Lasting Relief

WATER
RESISTANT
TECHNOLOGY

Qty: 10 Flexible Patches
(5 Per Resealable Pouch) x2
3 x 5 (7.62cm x 12.7cm)

APPLY FOR 36 HOURS

ION PHARMA
MADE IN
USA

INGREDIENTS AND APPEARANCE

METHYL SALICYLATE 10% 
methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82944-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82944-101-10	10 in 1 BOX	06/01/2023
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/01/2023

Labeler - ION PHARMA, LLC (118739596)