SALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]

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SALONPAS-HOT CAPSICUM (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]
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NDC 46581-700-01, 46581-700-03
Set ID ef5373aa-9857-4d01-95af-2d7716e54ae4
Category HUMAN OTC DRUG LABEL
Packager Hisamitsu Pharmaceutical Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • 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)
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