Label: SALONPAS-HOT CAPSICUM- capsaicin patch

  • NDC Code(s): 46581-700-01, 46581-700-03
  • 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 ingredient

    Capsicum extract  0.025% as Capsaicin

  • 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

    • 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 hours' 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

    butylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, natural rubber latex, polybutene, polyisobutylene, silicon dioxide, titanium dioxide, zinc oxide

  • Questions or comments?

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

  • Principal Display Panel

    OTC topical analgesics in patch format*
    WORLD'S BRAND NO.1

    Hisamitsu

    NDC#46581-700-01

    for temporary relief of minor aches and pains of muscles and joints associated with

    • Simple backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains

    Salonpas-HOT

    CAPSICUM Patch

    Topical Analgesic

    1 PATCH

    5.12" X 7.09" (13cm X 18cm)

    MADE IN JAPAN

    image of 1-patch pouch label

  • Principal Display Panel

    NEW!
    Value Pack

    3 FOLDED PATCHES in a pack

    Same Large Size
    5.12" X 7.09"
    (13 cm X 18 cm)

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

    Hisamitsu

    NDC#46581-700-03

    for temporary relief of minor aches and pains of muscles and joints associated with

    • Simple backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains

    Salonpas-HOT

    CAPSICUM Patch

    Topical Analgesic

    3 FOLDED PATCHES

    5.12" X 7.09" (13cm X 18cm)

    MADE IN JAPAN

    image of 3-patch pouch label

  • INGREDIENTS AND APPEARANCE
    SALONPAS-HOT CAPSICUM 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46581-700-011 in 1 POUCH11/26/1998
    14 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:46581-700-033 in 1 POUCH12/01/2018
    24 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 finalpart34811/26/1998
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)