SALONPAS PAIN RELIEF- menthol, methyl salicylate patch

Salonpas Pain Relief by

Drug Labeling and Warnings

Salonpas Pain Relief 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:

• 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 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 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.

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-styrene block copolymer, synthetic aluminum silicate

Questions or comments?

Toll free 1-87-SALONPASwww.salonpas.us

Principal Display Panel

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

Hisamitsu

NDC#46581-675-09
for temporary relief of mild to moderate pain

• Backache
• Sore Muscle
• Sprains
• Bruises

Salonpas
Pain Relief 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 LARGE PATCHES
3 15/16" X 5 1/2" (10cm X 14cm)

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

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

Principal Display Panel

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

Hisamitsu

NDC#46581-675-99
for temporary relief of mild to moderate pain

• Backache
• Sore Muscle
• Strains
• Bruises

HOW TO APPLY
1 Peel the center film.
2 Place on affected area.
3 Slide a film.
4 Slide the other film.

Salonpas
Pain Relief 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

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

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

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

Manufactured by
Hisamitsu Pharmaceutical Co., Inc.
JAPAN SAGA TOSU
MADE IN JAPAN

Distributed by
Hisamitsu America, Inc.
Florham Park, NJ 07932

FREE SAMPLE
NOT FOR RE-SALE

INGREDIENTS AND APPEARANCE

SALONPAS PAIN RELIEF 
menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46581-675
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: 46581-675-09	3 in 1 BOX	06/01/2018
1		3 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 46581-675-99	1 in 1 POUCH; Type 0: Not a Combination Product	05/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022029	06/01/2018

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