Active Ingredients (In Each Patch)
Menthol 3%
Methyl salicylate 10% (NSAID : nonsteroidal anti-inflammatory drug)
Salonpas Pain Relief Patch
FDA Label NDC 46581-670
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hisamitsu Pharmaceutical Co., Inc. for the product Salonpas Pain Relief (NDC 46581-670). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each patch), purpose, uses, warnings, stomach bleeding warning:, do not use, ask a doctor before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
OTC topical analgesics in patch format*
WORLD'S BRAND NO.1
Hisamitsu
NDC#46581-670-05
for temporary relief of mild to moderate pain
- Sore Muscle
- Sprains
- Backache
- Joint Pain
- Sore Muscle
- Sprains
- Backache
- Joint 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.
Hisamitsu
FREE SAMPLE
NOT FOR RE-SALE
minty scent
NDC#46581-670-99
for temporary relief of mild to moderate 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
Hisamitsu
NDC#46581-670-06
for temporary relief of mild to moderate 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
* Please review the disclaimer below.
