Salonpas Pain Relief

Dosage form: patch
Ingredients: MENTHOL 31.5mg, METHYL SALICYLATE 105mg
Labeler: Hisamitsu Pharmaceutical Co., Inc.
NDC Code: 46581-670

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

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

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

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

SALONPAS PAIN RELIEF 
menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-670
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL31.5 mg
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE105 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM SILICATE 
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:46581-670-153 POUCH in 1 BOX
15 PATCH in 1 POUCH
2NDC:46581-670-062 POUCH in 1 BOX
23 PATCH in 1 POUCH
3NDC:46581-670-051 POUCH in 1 BOX
35 PATCH in 1 POUCH
4NDC:46581-670-033 PATCH in 1 POUCH
5NDC:46581-670-011 PATCH in 1 POUCH
6NDC:46581-670-991 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02202904/25/2008
Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 12/2013
 
Hisamitsu Pharmaceutical Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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