Label: SALONPAS- camphor, menthol, methyl salicylate patch

  • NDC Code(s): 46581-110-14, 46581-110-20, 46581-110-60, 46581-110-99
  • Packager: Hisamitsu Pharmaceutical Co., Inc.
  • Category: HUMAN OTC DRUG LABEL

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 April 6, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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
    • 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:

    • 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, synthetic 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*
    WORLD'S BRAND NO.1

    Hisamitsu NDC#46581-110-60

    for temporary relief of minor aches and pains

    STIFF NECK
    SORE SHOULDER
    BACKACHE
    JOINT PAIN

    Salonpas

    Pain Relieving Patch

    APPLY FOR 8 HOURS

    60 PATCHES

    2.83" X 1.81" (7.2cm X 4.6cm)

    MADE IN JAPAN

    image of 60-patch box label

  • Principal Display Panel

    CUT OPEN HERE

    Hisamitsu NDC#46581-110-99

    Stiff Neck Sore Shoulder Backache Joint Pain

    Salonpas

    Pain Relieving Patch

    2 PATCHES

    2.83" X 1.81" (7.2cm X 4.6cm)

    SAMPLE ONLY / NOT FOR RE-SALE

    image of 2-patch sample pouch label

  • INGREDIENTS AND APPEARANCE
    SALONPAS 
    camphor, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-110
    Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)21.56 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL41.73 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE69.55 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:46581-110-603 in 1 BOX06/01/2015
    120 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:46581-110-201 in 1 BOX12/01/2015
    220 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:46581-110-992 in 1 POUCH; Type 0: Not a Combination Product07/01/2015
    4NDC:46581-110-147 in 1 BOX08/01/2016
    420 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/01/2015
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)