SALONPAS PAIN RELIEVING JET (MENTHOL, METHYL SALICYLATE) AEROSOL, SPRAY [HISAMITSU PHARMACEUTICAL CO., INC.]

SALONPAS PAIN RELIEVING JET (MENTHOL, METHYL SALICYLATE) AEROSOL, SPRAY [HISAMITSU PHARMACEUTICAL CO., INC.]
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NDC 46581-440-04, 46581-440-99
Set ID dd1ea3bf-891a-402e-8f43-14302bc9c3e5
Category HUMAN OTC DRUG LABEL
Packager Hisamitsu Pharmaceutical Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredients

    Menthol 3%

    Methyl salicylate 10%

  • Purpose

    Topical analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with:

    • strains
    • sprains
    • bruises
    • simple backache
    • arthritis
  • Warnings

    For external use only

    Allergy alert:

    If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    Flammable:

    • keep away from fire or flame
    • do not use where sparks come out
    • do not use in a confined space
    • do not puncture or incinerate container. Contents under pressure.
    • do not expose to temperature exceeding 120 degrees F (48 degrees C)

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed
    • avoid contact with the eyes, mucous membranes or rashes
    • do not bandage tightly
    • avoid inhalation

    Stop use and ask a doctor if

    • skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
    • conditions worsen
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and over:

    • shake the can very well before use 
    • to avoid frostbite, hold the can 4 inches (10 cm) away from the skin, and spray each affected area for no longer than 1 second
    • apply to affected area not more than 3 to 4 times daily

    Children under 12 years of age: consult a docutor

  • Other information

    • Avoid storing product in direct sunlight and heat
  • Inactive ingredient

    alcohol

  • Questions or comments?

    Toll free 1-800-826-8861

    www.salonpas.us

  • Principal Display Panel

    Hisamitsu

    Salonpas Pain Relieving JET SPRAY

    NDC#46581-440-04

    4 FL OZ (118mL)

    MADE IN JAPAN

    image of 4floz CAN label

  • Principal Display Panel

    NDC#46581-440-99

    FREE SAMPLE

    NOT FOR RE-SALE

    Salonpas pain relieving JET SPRAY

    1 FL OZ (29.5mL)

    Hisamitsu

    Distributed by

    Hisamitsu America, Inc.

    Florham Park, NJ 07932

    image of 1floz CAN label

  • INGREDIENTS AND APPEARANCE
    SALONPAS PAIN RELIEVING JET 
    menthol, methyl salicylate aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-440
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.0 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46581-440-0414.6 g in 1 CAN; Type 0: Not a Combination Product05/01/2011
    2NDC:46581-440-993.6 g in 1 CAN; Type 0: Not a Combination Product05/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/01/2011
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)
    Registrant - Hisamitsu Pharmaceutical Co., Inc. (690539713)