SALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]

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SALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]
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NDC 46581-210-06
Set ID 5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5
Category HUMAN OTC DRUG LABEL
Packager Hisamitsu Pharmaceutical Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active ingredients

    Camphor 3.1%

    Menthol 6.0%

    Methyl salicylate 10.0%

  • Purpose

    Topical analgesic

  • Uses

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

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

    For external use only

    Allergy alert:

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

    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

    Stop use and ask a doctor if

    • rash, itching or excessive skin irritation develops
    • contisions 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:

    • clean and dry affected area
    • remove patch from film
    • apply to affected area not more than 3 to 4 times daily
    • remove patch from the skin after at most 8-hour application

    Children under 12 years of age: consult a doctor

  • Other information

    • avoid storing product in direct sunlight
    • protect product from excessive moisture
  • Inactive ingredients

    mineral oil, perfume, polyisobutylene, styrene-isoprene-styrene block copolymer, aluminum silicate, terpene resin, titanium dioxide

  • Questions or comments?

    Toll free 1-800-826-8861   www.salonpas.us

  • Principal Display Panel

    OTC topical analgesics in patch category*
    WORLDS'S BRAND NO.1

    Hisamitsu

    NDC#46581-210-06

    for temporary relief of minor aches and pains

    BACKACHE
    SORE SHOULDER
    STIFF NECK
    JOINT PAIN

    Salonpas

    Pain Relieving Patch

    LARGE

    APPLY FOR 8 HOURS

    6 PATCHES

    5.67" X 3.62" (14.4 X 9.2cm)

    MADE IN JAPAN

    image of 6-patch box label

  • INGREDIENTS AND APPEARANCE
    SALONPAS 
    camphor, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-210
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)86.24 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL166.92 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE278.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46581-210-061 in 1 BOX05/17/2016
    16 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/17/2016
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)
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