FDA.reportPublic FDA data

SATOHAP Cool & Hot - 5 pads in 1 pouch - (10cm BY 7cm each pad)

Manufacturer
Sato Pharmaceuticals Co., Ltd.
Effective date
2026-07-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-04 03:33:32

Label at a glance#

ProductSATOHAP COOL and HOT
Active ingredientCAPSAICIN, CAMPHOR (SYNTHETIC), LEVOMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints due to: simple backache arthritis strains bruises sprains

Dosage and administration

Adults and children 4 years of age and older: remove polyethylene film and place adhesive pad over affected area. Do not use more than 2 patches per day. Children under 4 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.1%

Capsaicin 0.025%

Menthol 6%

Purpose

OTC - PURPOSE SECTION

External analgesic

External analgesic

External analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on irritated or damaged skin
  • on wounds

Ask a doctor or pharmacist before use if you have

OTC - ASK DOCTOR/PHARMACIST SECTION

  • any concerns about using this product

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes or mucus membranes
  • do not bandage tightly
  • do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive irritation of the skin develops
  • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
  • you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)

when using for pain of arthritis:

  • pain persists for more than 10 days
  • redness is present
  • in conditions affecting children under 12 years of age

Report any unexpected side effects from the use of this product to the FDA MedWatch Program

ADVERSE REACTIONS SECTION

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 4 years of age and older: remove polyethylene film and place adhesive pad over affected area.
  • Do not use more than 2 patches per day.
  • Children under 4 years of age: Consult a doctor.

Other information

OTHER SAFETY INFORMATION

  • keep pouch tightly closed
  • keep product protected from heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, dried aluminum hydroxide gel, edetate disodium, emulsion of methyl acrylate and 2-ethylhexyl acrylate copolymer, glycerin, malic acid, partially neutralized polyacrylate, polysorbate 80, polyvinyl alcohol, sorbitol solution, talc, titanium dioxide, and water on a polyester fiber backing and covered with a polyethylene film.

SATOHAP COOL & HOT 10cm BY 7cm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SATOHAP COOL & HOT 10cm BY 7CMSATOHAP COOL & HOT 10cm BY 7CM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-62249873-622-01

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
CAPSAICINS07O44R1ZMACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
LEVOMENTHOLBZ1R15MTK7ACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
MALIC ACID817L1N4CKPIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
2-ETHYLHEXYL ACRYLATEHR49R9S6XGIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
TALC7SEV7J4R1UIACT
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)M4PPW69Y4HIACT
METHYL ACRYLATEWC487PR91HIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-09-01full-release2026-06-01 00:22:52

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 COOL and HOTCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceuticals Co., Ltd.232a4c76-1a0c-2f4b-e063-6394a90a88492026-07-31Warnings, Adverse reactionsExact identifier
ndc (package): 49873-622-01
ndc (product): 49873-622
ndc11 (package): 49873062201
spl id: 57efe410-5fbf-ea8c-e063-6394a90ae3da
spl set id: 232a4c76-1a0c-2f4b-e063-6394a90a8849

Reported adverse events (FAERS/openFDA)#

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