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

SALONPAS PAIN RELIEVING HOT-L (CAPSAICIN, MENTHOL) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]
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NDC 46581-890-01, 46581-890-03, 46581-890-99
Set ID dd2325ae-ec41-4201-82af-0415cbccd880
Category HUMAN OTC DRUG LABEL
Packager Hisamitsu Pharmaceutical Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredients

    Capsicum extract   0.025% as Capsaicin

    Menthol 1.25%

  • 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
    • remove 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, edetate disodium, gelatin, glycerin, magnesium aluminometasilicate, oleyl alcohol, polyacrylic acid, polyethylene glycol, polyvinyl alcohol, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, water

  • Questions or comments?

    Toll free 1-800-826-8861  www.salonpas.us

  • Principal Display Panel

    LARGE

    NDC#46581-890-03

    for minor aches and pain relief

    • Shoulder
    • Upper Back
    • Lower Back

    Salonpas pain relieving GEL-PATCH HOT-L

    Capsaicin 0.025%

    Menthol 1.25%

    LASTS UP TO 8 HOURS

    Pain Relieving Ointment on a Breathable Cloth

    STRETCHABLE

    3 patches

    3 15/16 X 7 7/8 (10cm X 20cm)

    Hisamitsu

    image of 3-patch box label

  • INGREDIENTS AND APPEARANCE
    SALONPAS  PAIN RELIEVING HOT-L
    capsaicin, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-890
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSAICIN0.025 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46581-890-031 in 1 BOX
    13 in 1 POUCH
    120 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:46581-890-011 in 1 POUCH
    220 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:46581-890-991 in 1 POUCH
    320 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 finalpart34805/01/2011
    Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)