SALONPAS ARTHRITIS PAIN- menthol, methyl salicylate patch

Salonpas Arthritis Pain by

Drug Labeling and Warnings

Salonpas Arthritis Pain by is a Otc medication manufactured, distributed, or labeled by Hisamitsu Pharmaceutical Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each patch)

Menthol 3%

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

Purpose

Topical analgesic

Uses

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

• arthritis
• sprains
• strains
• bruises
• simple backache

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 wouds 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 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 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 beeding.
• rash, itching or skin irritaion 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 health professional before use. It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor 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.

Directions

Adults 18 years 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 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

Other information

• store at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit)
• 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 inredients

alicyclic saturated hydrocarbon resin, baking cloth, film, mineral oil, polyisobutylene, polyisobutylene 1,200,000, styrene-isoprene-sryrene block copolymer, synthetic aluminum silicate

Questions or comments?

Toll free 1-87-SALONPASwww.salonpas.us

Principal Display Panel

Hisamitsu

NDC#46581-685-09

LARGE
3 15/16" X 5 1/2"

for temporary relief of mild to moderate pain

Arthritis
Joint Pain
Sprains
Strains

Salonpas
Arthritis Pain Patch

APPLY FOR 8-12 HOURS

Menthol 3%
Methyl Salicylate 10%

Topical Analgesic

FDA APPROVED NON-PRESCRIPTION PAIN RELIEVING PATCH
EFFECTIVENESS CONFIRMED IN CLINICAL TRIAL

9 pathces

3 15/16" X 5 1/2"(10cm X 14cm)

Package not child resistant.
Keep our of reach of children.

* DO NOT USE MORE THAN ONE SALONPAS PATCH AT A TIME. SEE DIRECTIONS.

INGREDIENTS AND APPEARANCE

SALONPAS ARTHRITIS PAIN 
menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46581-685
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	63 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	210 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46581-685-09	3 in 1 BOX	11/01/2022
1		3 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022029	11/01/2022

Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)