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
  • 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 December 19, 2019

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

    iimage 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 not finalpart34801/01/2018
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)