FDA.reportPublic FDA data

Salonpas pain relieving hot - Hisamitsu Pharmaceutical Co., Inc.

Manufacturer
Hisamitsu Pharmaceutical Co., Inc.
Effective date
2026-07-07
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-07-17 21:45:43

Label at a glance#

ProductSalonpas pain relieving hot
Active ingredientCAPSAICIN, MENTHOL
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

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 hour-application Children under 12 years of age: consult a doctor

Storage and handling

Avoid storing product in direct sunlight Protect product from excessive moisture

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsicum extract 0.025% as Capsaicin
Menthol 1.25%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • use only 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

OTC - STOP USE SECTION

  • skin reactions such as redness, itching, rash, excessive irritation, buring sensation, swelling or blistering occur
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 hour-application

Children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

edetate disodium, gelatin, glycerin, magnesium aluminometasilicate, methylacrylate/2-ethylhexyl acrylate copolymer, nonoxynol, oleyl alcohol, polyacrylic acid, polyvinyl alcohol, propylene glycol, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, water, methyparaben, propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTC topical analgesics in patch category*
WORLD'S BRAND NO.1

Hisamitsu

NDC#46581-871-06

for minor aches and pain relief

Back
Neck
Shoulders
Knees and Elbows
Salonpas Pain Relieving Gel-Patch HOT

Capsaicin 0.025%
Menthol 1.25%

APPLY FOR 8 HOURS

STRETCHABLE

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

MADE IN JAPAN

image of 6-patch box labelimage of 6-patch box label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46581-871-06EA - Each46581-871f2503576-4098-4f88-89c3-43eaf65fca8812020-07-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46581-87146581-871-06, 46581-871-99

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMACTIB
MENTHOLL7T10EIP3AACTIB
EDETATE DISODIUM7FLD91C86KIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SILODRATE9T3UU8T0QKIACT
OLEYL ALCOHOL172F2WN8DVIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-12-15full-release2026-06-01 01:25:29

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salonpas pain relieving hotCAPSAICIN, MENTHOLHisamitsu Pharmaceutical Co., Inc.d2aa8820-a947-404b-b617-e692fbd165022026-07-07WarningsExact identifier
ndc (package): 46581-871-06
ndc (package): 46581-871-99
ndc (product): 46581-871
ndc11 (package): 46581087199
ndc11 (package): 46581087106
spl id: 0bd26dcb-64bd-4150-bfb5-a65a17d0cc84
spl set id: d2aa8820-a947-404b-b617-e692fbd16502

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.