Label: SALONPAS- camphor, menthol, methyl salicylate patch

  • NDC Code(s): 46581-210-06
  • Packager: Hisamitsu Pharmaceutical Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 27, 2018

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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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