Label: SALONPAS PAIN RELIEVING HOT-L- capsaicin, menthol patch

  • Category: HUMAN OTC DRUG LABEL

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 November 27, 2015

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!