Label: SALONPAS PAIN RELIEVING HOT LARGE- capsaicin patch

  • NDC Code(s): 46581-750-01, 46581-750-03, 46581-750-99
  • 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 16, 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

    • 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)