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

SALONPAS PAIN RELIEVING PATCH HOT LARGE (CAPSAICIN) OINTMENT [HISAMITSU PHARMACEUTICAL CO., INC.]
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NDC 46581-750-01, 46581-750-03, 46581-750-99
Set ID b3b35d6c-d752-4e5e-872f-23f338c1c567
Generic Name
Product Class
Product Number
Application Number PART348
  • 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  www.salonpas.us

  • Principal Display Panel

    Cut open easily by hand

    LARGE

    NDC#46581-750-01

    for minor aches and pain relief

    • Shoulder
    • Upper Back
    • Lower Back

    1 Peel the center film.

    2 Place on affected area.

    3 Slide a film.

    4 Slide the other film.

    Salonpas pain relieving PATCH HOT LARGE

    Pain Relieving Ointment on a Breathable Cloth

    Capsaicin 0.025%

    LASTS UP TO 8 HOURS

    STRETCHABLE and FLEXIBLE

    1 LARGE patch

    Hisamitsu

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

    Manufactured by

    Hisamitsu Pharmaceutical Co., Inc.

    JAPAN SAGA TOSU

    MADE IN JAPAN

    Distributed by

    Hisamitsu America, Inc.

    Florham Park, NJ 07932

    image of 1-patch pouch label

  • INGREDIENTS AND APPEARANCE
    SALONPAS  PAIN RELIEVING HOT LARGE
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-750
    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:46581-750-031 in 1 BOX01/01/2012
    13 in 1 POUCH
    12.10 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:46581-750-011 in 1 POUCH01/01/2012
    22.10 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:46581-750-991 in 1 POUCH01/01/2012
    32.10 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)

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