Label: SALONPAS PAIN RELIEF- menthol, methyl salicylate patch

  • NDC Code(s): 46581-675-09, 46581-675-99
  • Packager: Hisamitsu Pharmaceutical Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 3, 2019

If you are a consumer or patient please visit this version.

  • 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.

    image of 9-patch box 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

  • INGREDIENTS AND APPEARANCE
    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:46581-675-991 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)