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

Hisamitsu

NDC#46581-670-05

for temporary relief of mild to moderate pain

Sore Muscle
Sprains
Backache
Joint Pain
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

5 PATCHES

2 3/4" X 3 15/16" (7cm X 10cm)

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 5-patch box label

Principal Display Panel

Hisamitsu

FREE SAMPLE

NOT FOR RE-SALE

minty scent

NDC#46581-670-99

for temporary relief of mild to moderate pain

Sore Muscle
Sprains
Backache
Joint Pain
1 Peel the center film.

2 Place on affected area.

3 Slide the film forward.

4 Slide the other film backward.

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 patch

2 3/4" X 3 15/16" (7cm X 10cm)

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 Pharmacetuical Co., Inc.

JAPAN SAGA TOSU

MADE IN JAPAN

Disributed by

Hisamitsu America, Inc.

Florham Park, NJ 07932

image of 1-patch sample pouch label

Principal Display Panel

Hisamitsu

NDC#46581-670-06

for temporary relief of mild to moderate pain

Sore Muscle
Sprains
Backache
Joint Pain
BONUS PACK!

ONE FREE PATCH

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

6 patches

2 3/4" X 3 15/16" (7cm X 10cm)

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 6-patch bonus box label

SALONPAS PAIN RELIEF 
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-670
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL31.5 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE105 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46581-670-153 in 1 BOX06/26/2008
15 in 1 POUCH; Type 0: Not a Combination Product
2NDC:46581-670-204 in 1 BOX02/01/2020
25 in 1 POUCH; Type 0: Not a Combination Product
3NDC:46581-670-062 in 1 BOX12/31/2013
33 in 1 POUCH; Type 0: Not a Combination Product
4NDC:46581-670-051 in 1 BOX05/22/2008
45 in 1 POUCH; Type 0: Not a Combination Product
5NDC:46581-670-033 in 1 POUCH; Type 0: Not a Combination Product09/26/2008
6NDC:46581-670-011 in 1 POUCH; Type 0: Not a Combination Product07/06/2011
7NDC:46581-670-991 in 1 POUCH; Type 0: Not a Combination Product07/06/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02202904/25/2008
Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 9/2021
Document Id: 34749e27-1251-4cca-9ad3-b4b2b0f06767
Set id: 724bc4d3-0bc1-4275-a23b-4bbc62fbc0d2
Version: 16
Effective Time: 20210915
 
Hisamitsu Pharmaceutical Co., Inc.