FDA.reportPublic FDA data

Salonpas

Manufacturer
Hisamitsu Pharmaceutical Co., Inc.
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:15

Label at a glance#

ProductSalonpas
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure9 sections

Indications and uses

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

Dosage and administration

Adults and children 12 years of age and over: clean and dry affected area remove patch from film 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

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

OTC - ASK DOCTOR SECTION

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash, itching or excessive skin irritation develops
  • contisions 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 patch from film
  • 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

mineral oil, perfume, polyisobutylene, styrene-isoprene-styrene block copolymer, aluminum silicate, terpene resin, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Hisamitsu

NDC#46581-210-06

for temporary relief of minor aches and pains

BACKACHE
SORE SHOULDER
STIFF NECK
JOINT PAIN

Salonpas

Pain Relieving Patch

LARGE

APPLY FOR 8 HOURS

6 PATCHES

5.67" X 3.62" (14.4 X 9.2cm)

MADE IN JAPAN

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSN4
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD4
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46581-210-06Salonpas6 in 1 POUCHPATCH64
46581-210-06Salonpas1 in 1 BOXPATCH14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46581-210SALONPAS (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]4Current NDC, Legacy NDC, 2 package rows20241205_5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46581-210-06EA - Each46581-210044777aa-bc9c-4b37-8d33-cdd664b9116612020-07-13

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46581-21046581-210-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
MINERAL OILT5L8T28FGPIACT
ALUMINUM SILICATET1FAD4SS2MIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

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
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff52024-12-03WarningsExact identifier
ndc (package): 46581-210-06
ndc (product): 46581-210
ndc11 (package): 46581021006
spl id: 5d0c2aa9-2ab6-4ad2-994f-4488d5121400
spl set id: 5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff5

Reported adverse events (FAERS/openFDA)#

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