FDA.reportPublic FDA data

Salonpas LIDOCAINE PLUS

Manufacturer
Hisamitsu America, Inc.
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:40:17

Label at a glance#

ProductSalonpas LIDOCAINE PLUS
Active ingredientBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE
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 apply to affected area not more than 3 to 4 times daily Children under 12 years of age: consult a doctor

Storage and handling

Avoid storing product in direct sunlight Protect product from excessive moisture Store with lid closed tighly

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzyl alcohol  10%

Lidocaine HCl  4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Flammable:

SAFE HANDLING WARNING SECTION

Keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • in large quantities
  • 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

  • skin reactions occur, such as rash, itching, redness, irritaion, pain, swelling and blistering
  • 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
  • apply to affected area not more than 3 to 4 times daily

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
  • Store with lid closed tighly

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, aminomethyl propanol, carbomer, SD alcohol 40-B, water

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hisamitsu

NDC#55328-901-03

No-Mess Roll On

Salonpas LIDOCAINE PLUS Pain Relieving Liquid

TOPICAL ANALGESIC

4% LIDOCAIN MAXIMUM STRENGTH *1
plus 10% Benzyl alcohol

2 Powerful Anesthetics
Fast Acting
Numbing Relief
Unscented
MADE IN USA

3 FL OZ (88 mL)

image of 3 FL OZ bottleimage of 3 FL OZ bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionPSN4
1943537benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical SolutionSCD4
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55328-901-03Salonpas LIDOCAINE PLUS80 g in 1 TUBELIQUID804
55328-901-03Salonpas LIDOCAINE PLUS1 in 1 BOXLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55328-901SALONPAS LIDOCAINE PLUS (BENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [HISAMITSU AMERICA, INC.]4Current NDC, Legacy NDC, 2 package rows20241205_ea5b4a7f-d47d-4dbd-9288-c01329e387e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55328-901-03ML - Milliliter55328-90145b99e7c-9b83-422c-9b06-a90589df4a2412020-07-13

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55328-90155328-901-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
alcohol3K9958V90MIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
water059QF0KO0RIACT

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 LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
ndc (package): 55328-901-03
ndc (product): 55328-901
ndc11 (package): 55328090103
spl id: cd6de492-966e-4127-aca7-dc865243b42a
spl set id: ea5b4a7f-d47d-4dbd-9288-c01329e387e5

Reported adverse events (FAERS/openFDA)#

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