Label: SALONPAS PAIN RELIEVING HOT- capsaicin, menthol patch

  • NDC Code(s): 46581-871-06, 46581-871-99
  • Packager: Hisamitsu Pharmaceutical Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2023

If you are a consumer or patient please visit this version.

  • Active ingredients

    Capsicum extract 0.025% as Capsaicin
    Menthol 1.25%

  • Purpose

    Topical analgesic

  • Uses

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

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

    For external use only

    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
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower

    Stop use and ask a doctor if

    • skin reactions such as redness, itching, rash, excessive irritation, buring 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:

    • clean and dry affected area
    • remove film from patch and apply to the skin (see illustration)
    • 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

    edetate disodium, gelatin, glycerin, magnesium aluminometasilicate, methylacrylate/2-ethylhexyl acrylate copolymer, nonoxynol, oleyl alcohol, polyacrylic acid, polyvinyl alcohol, propylene glycol, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, water

  • 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#46581-871-06

    for minor aches and pain relief

    Back
    Neck
    Shoulders
    Knees and Elbows
    Salonpas Pain Relieving Gel-Patch HOT

    Capsaicin 0.025%
    Menthol 1.25%

    APPLY FOR 8 HOURS

    STRETCHABLE

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

    MADE IN JAPAN

    image of 6-patch box label

  • Principal Display Panel

    IMPROVED ADHESION*1

    Hisamitsu

    NDC#46581-871-99

    for minor aches and pain relief

    Back
    Neck
    Shoulders
    Knees and Elbows
    Salonpas Pain Relieving Gel-Patch HOT

    Capsaicin 0.025%, Menthol 1.25%

    APPLY FOR 8 HOURS

    STRETCHABLE

    Better adhesion*2
    Rounded corner

    Easy application
    Center-cut film

    All direction stretchable

    SAMPLE NOT FOR RE-SALE

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

    MADE IN JAPAN

    image of 1-patch sample sachet label

  • INGREDIENTS AND APPEARANCE
    SALONPAS  PAIN RELIEVING HOT
    capsaicin, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-871
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSAICIN0.025 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILODRATE (UNII: 9T3UU8T0QK)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46581-871-062 in 1 BOX01/01/2018
    13 in 1 POUCH
    17 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:46581-871-991 in 1 POUCH11/01/2018
    27 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2018
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)