Label: SALONPAS ARTHRITIS PAIN- menthol, methyl salicylate patch

  • NDC Code(s): 46581-685-09
  • Packager: Hisamitsu Pharmaceutical Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 13, 2024

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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:

    • arthritis
    • sprains
    • strains
    • bruises
    • simple backache
  • 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:

    • 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-sryrene block copolymer, synthetic aluminum silicate

  • Questions or comments?

    Toll free 1-87-SALONPASwww.salonpas.us

  • Principal Display Panel

    Hisamitsu

    NDC#46581-685-09

    LARGE
    3 15/16" X 5 1/2"

    for temporary relief of mild to moderate pain

    Arthritis
    Joint Pain
    Sprains
    Strains

    Salonpas
    Arthritis Pain 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 pathces

    3 15/16" X 5 1/2"(10cm X 14cm)

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

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

    image of 9-patch box label

  • INGREDIENTS AND APPEARANCE
    SALONPAS ARTHRITIS PAIN 
    menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-685
    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:46581-685-093 in 1 BOX11/01/2022
    13 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02202911/01/2022
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)
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