FDA.reportPublic FDA data

Satohap Lidocaine HCl 4% Pain Relieving Lotion

Manufacturer
Sato Pharmaceutical Co., Ltd. | Fuji Seal, Inc.
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:52:26

Label at a glance#

ProductSatohap Lidocaine Hydrochloride 4 Percent Pain Relieving
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Lidocaine hydrochloride 4%

OTC - PURPOSE SECTION

Purpose

Lidocaine hydrochloride - Topical analgesic

INDICATIONS & USAGE SECTION

Uses

For temporary relief of pain and itching

WARNINGS SECTION

Warnings

For external use only

Flammable: Keep away from fire and flame

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • a rash or irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailly
  • children under 12 years of age: do not use, ask a doctor

OTHER SAFETY INFORMATION

Other information

  • avoid storing in direct sunlight
  • store with lid tightly closed

INACTIVE INGREDIENT SECTION

Inactive ingredients alcohol, propylene glycol, sodium hydroxide, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1796087lidocaine HCl 4 % Topical LotionPSN5
1796087lidocaine hydrochloride 40 MG/ML Topical LotionSCD5
1796087lidocaine HCl 4 % Topical LotionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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
49873-618-01Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving1 in 1 CARTONLOTION15
49873-618-01Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving80 mL in 1 BOTTLE, WITH APPLICATORLOTION805

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-61849873-618-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
Satohap Lidocaine Hydrochloride 4 Percent Pain RelievingLIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.f7faddb2-5153-4fdd-a5ef-778182cef4602026-03-31WarningsExact identifier
ndc (package): 49873-618-01
ndc (product): 49873-618
ndc11 (package): 49873061801
spl id: 4e59be40-2b3d-a435-e063-6294a90a46cb
spl set id: f7faddb2-5153-4fdd-a5ef-778182cef460

Reported adverse events (FAERS/openFDA)#

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