FDA.reportPublic FDA data

Salonpas Pain Relieving LIDOCAINE 4% FLEX

Manufacturer
Hisamitsu Pharmaceutical Co., Inc.
Effective date
2024-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:29

Label at a glance#

ProductSalonpas Pain Relieving LIDOCAINE 4% FLEX
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For temporary relief of pain

Dosage and administration

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 1 patch at a time 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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any igredients 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

  • skin reactions such as redness, itching, rash, excessive irritation, burning 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
  • peel film from patch and apply to the skin (see illustration)
  • apply 1 patch at a time 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

aluminum silicate, mineral oil, polyisobutylene, propylene glycol, styrene-isoprene-styrene block copolymer, terpene resin

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#46581-840-07
for temporary relief of pain
PATCH CONTOURS TO YOUR BODY
Adheres as you move, bend, twist, or flex
Salonpas Pain Relieving FLEX Patch LIDOCAINE 4%
APPLY FOR UP TO 8 HOURS
MAXIMUM OTC STRENGTH
• Stretchable
• Thin Fabric
• Strong Adhesion
7 PATCHES
2 3/4" X 3 15/16" (7cm X 10cm)
MADE IN JAPAN

image of 7-patch box labelimage of 7-patch box label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46581-840-07Salonpas Pain Relieving LIDOCAINE 4% FLEX7 in 1 BOXPATCH72
46581-840-07Salonpas Pain Relieving LIDOCAINE 4% FLEX1 in 1 POUCHPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46581-840SALONPAS PAIN RELIEVING LIDOCAINE 4% FLEX (LIDOCAINE) PATCH [HISAMITSU PHARMACEUTICAL CO., INC.]2Current NDC, Legacy NDC, 2 package rows20240118_9507f727-c49f-4de4-9d64-b6d977d568ab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46581-840-07EA - Each46581-84065f4448a-2b36-4dc2-b710-7e0242a6442f12022-12-07

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46581-84046581-840-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ALUMINUM SILICATET1FAD4SS2MIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
Salonpas Pain Relieving LIDOCAINE 4% FLEXLIDOCAINEHisamitsu Pharmaceutical Co., Inc.9507f727-c49f-4de4-9d64-b6d977d568ab2024-01-17WarningsExact identifier
ndc (package): 46581-840-07
ndc (product): 46581-840
ndc11 (package): 46581084007
spl id: d8b3f877-b811-4466-b0c4-905a7192a151
spl set id: 9507f727-c49f-4de4-9d64-b6d977d568ab

Reported adverse events (FAERS/openFDA)#

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