Label: SALONPAS PAIN RELIEVING HOT- capsaicin patch

  • NDC Code(s): 46581-730-01, 46581-730-05, 46581-730-99
  • 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 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

    • 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)