SALONPAS PAIN RELIEF- menthol, methyl salicylate patch 
Hisamitsu Pharmaceutical Co., Inc.

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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:

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:

Children under 18 years of age: do not use; this product has not been shown to work in children

Other information

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.

image of 9-patch box label

Principal Display Panel

CUT OPEN HERE

NDC#46581-675-01

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)

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

Hisamitsu

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

Manufactured by
Hisamitsu Pharmaceutical Co., Inc.
408, Tashirodaikan-machi, Tosu, Saga, Japan

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

MADE IN JAPAN

image of 1-patch pouch label

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

image of 1-patch sample label

SALONPAS PAIN RELIEF 
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-675
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL63 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE210 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46581-675-093 in 1 BOX06/01/2018
13 in 1 POUCH; Type 0: Not a Combination Product
2NDC:46581-675-011 in 1 POUCH; Type 0: Not a Combination Product08/01/2020
3NDC:46581-675-991 in 1 POUCH; Type 0: Not a Combination Product05/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02202906/01/2018
Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 9/2021
Document Id: f74235b4-c91a-49d3-a02b-891a5ba2e068
Set id: acd7ba91-221a-485a-ad1f-dd41ed155656
Version: 5
Effective Time: 20210915
 
Hisamitsu Pharmaceutical Co., Inc.