SALONPAS PAIN RELIEVING HOT (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]

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  • SALONPAS PAIN RELIEVING HOT (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]

SALONPAS PAIN RELIEVING HOT (CAPSAICIN) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]
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NDC 46581-730-01, 46581-730-05, 46581-730-99
Set ID 58cba117-a821-42ee-a68e-c788532196a1
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

    • do not use otherwise than 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.
    • peel 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 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

    aluminum silicate, butylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, mineral oil, polyisobutylene, polyisobutylene 1,200,000, styrene-isoprene-styrene block copolymer

  • Questions or comments?

    Toll free 1-800-826-8861, Weekdays, 9AM to 5PM (PST) www.salonpas.us

  • Principal Display Panel

    NDC#46581-730-05

    for minor aches and pain relief

    • Shoulder
    • Neck
    • Leg
    • Back

    Salonpas pain relieving PATCH HOT
    Pain Relieving Ointment on a Breathable Cloth
    LASTS UP TO 8 HOURS
    Capsaicin 0.025%

    STRETCHABLE and FLEXIBLE

    5 patches 2 3/4" X 3 15/16" (7cm X 10cm)

    Hisamitsu

    image description

  • Principal Display Panel

    Cut open easily by hand

    FREE SAMPLE NOT FOR RE-SALE

    NDC#46581-730-99

    for minor aches and pain relief

    • Shoulder
    • Neck
    • Leg
    • Back

    1 Peel the center film.
    2 Place on affected area.
    3 Slide the film forward.
    4 Slide the other film backward.

    Salonpas pain relieving PATCH HOT
    Pain Relieving Ointment on a Breathable Cloth
    Capsaicin 0.025%

    LASTS UP TO 8 HOURS

    STRETCHABLE AND FLEXIBLE

    1 patch
    2 3/4" X 3 15/16" (7cm X 10cm)

    Hisamitsu

    Manufactured by
    Hisamitsu Pharmaceutical Co., Inc.
    JAPAN SAGA TOSU
    MADE IN JAPAN

    Distributed by
    Hisamitsu America, Inc.
    Torrance, CA 90503

    image description

  • INGREDIENTS AND APPEARANCE
    SALONPAS  PAIN RELIEVING HOT
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-730
    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
    Aluminum silicate (UNII: T1FAD4SS2M)  
    Butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    Mineral oil (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46581-730-051 in 1 BOX01/01/2012
    15 in 1 POUCH
    11.05 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:46581-730-011 in 1 POUCH01/01/2012
    21.05 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:46581-730-991 in 1 POUCH01/01/2012
    31.05 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 finalpart34801/01/2012
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)
    Registrant - Hisamitsu Pharmaceutical Co., Inc. (690539713)
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