FDA.reportPublic FDA data

Satohap Lidocaine 4% Pain Relieving Pad

Manufacturer
Sato Pharmaceutical Co., Ltd. | Nipro Corporation
Effective date
2023-11-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:22:21

Label at a glance#

ProductSatohap Lidocaine 4% Pain Relieving Pad
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For temporary relief of pain

Dosage and administration

adults and children over 12 years: clean and dry affected area peel off protective backing and apply sticky side to affected area use 1 patch for up to 8 hours children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

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 ingredients of this product
  • in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this carton.
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children and pets.

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 over 12 years:

  • clean and dry affected area
  • peel off protective backing and apply sticky side to affected area
  • use 1 patch for up to 8 hours

children 12 years or younger: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • avoid storing product in direct sunlight
  • protect product from excessive moisture
  • store at 68°-77°F (20°-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, diethylene glycol monoethyl ether, dihydroxyaluminum aminoacetate, edetate disodium, gelatin, glycerin, methylparaben, partially neutralized polyacrylate, phosphoric acid, polysorbate 80, polyvinyl alcohol, propylene glycol, propylparaben, sorbitol, tartaric acid, urea, water, on a breathable polyester fabric with a removable polypropylene protective cover

Satohap Lidocaine 4% Pain Relieving Pad

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Satohap Lidocaine 4% Pain Relieving Pad (front)Satohap Lidocaine 4% Pain Relieving Pad (front)

Satohap Lidocaine 4% Pain Relieving Pad

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Satohap Lidocaine 4% Pain Relieving Pad (back)Satohap Lidocaine 4% Pain Relieving Pad (back)

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-61749873-617-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
EDETATE DISODIUM7FLD91C86KIACT
UREA8W8T17847WIACT
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)M4PPW69Y4HIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
METHYLPARABENA2I8C7HI9TIACT
PHOSPHORIC ACIDE4GA8884NNIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
094a93d5-d88d-1d3f-e063-6294a90a3b3bb1340e80-174a-124d-e053-2a95a90a4c7a2023-11-03WarningsExact identifier
spl id: 094a93d5-d88d-1d3f-e063-6294a90a3b3b
spl set id: b1340e80-174a-124d-e053-2a95a90a4c7a

Reported adverse events (FAERS/openFDA)#

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