FDA.reportPublic FDA data

Satohap Lotion (Cool Type)

Manufacturer
Sato Pharmaceutical Co., Ltd.
Effective date
2023-11-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:06:41

Label at a glance#

ProductSatohap Cool Type
Active ingredientCAMPHOR (SYNTHETIC), LEVOMENTHOL, METHYL SALICYLATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Camphor

Menthol

Methyl salicylate

OTC - PURPOSE SECTION

Purpose

Camphor   External analgesic

Menthol   External analgesic

Methyl salicylate   External analgesic

INDICATIONS & USAGE SECTION

Uses  Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

WARNINGS SECTION

Warnings

For external use only

Flammable: Keep away from fire or flame

OTC - DO NOT USE SECTION

Do not use

  • on wounds
  • on irritated, broken, or damaged skin
  • otherwise than as directed

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles) because doing so can increase the risk of serious burns

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
  • excessive irritation of the skin develops
  • nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
  • 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
  • you experience pain, swelling, or blistering of the skin (this product should not cause pain or skin damage)

USER SAFETY WARNINGS SECTION

Warning-Rare cases of serious burns have been reported to occur on the skin where OTC external analgesics were applied.  Read and follow all directions and warnings on this label.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 3 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 3 years of age:  consult your physician
  • refer to the above warnings; use otherwise than as directed may be dangersous

OTHER SAFETY INFORMATION

Other information

  • keep container tightly closed
  • store at room temperature (20° to 25° C or 68° to 77° F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

alcohol, propylene glycol, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2672725camphor 5 % / menthol 6 % / methyl salicylate 10 % Topical LotionPSN4
2672725camphor 50 MG/ML / menthol 60 MG/ML / methyl salicylate 100 MG/ML Topical LotionSCD4
2672725camphor 5 % / menthol 6 % / methyl salicylate 10 % Topical LotionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-620-01Satohap Cool Type1 in 1 CARTONLOTION14
49873-620-01Satohap Cool Type45 mL in 1 BOTTLELOTION454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-620SATOHAP COOL TYPE (CAMPHOR, MENTHOL, METHYL SALICYLATE) LOTION [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20240105_fe07a00a-2699-44d3-887d-bd068948ad7b.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-62049873-620-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
LEVOMENTHOLBZ1R15MTK7ACTIB
METHYL SALICYLATELAV5U5022YACTIB

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 Cool TypeCAMPHOR, MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.fe07a00a-2699-44d3-887d-bd068948ad7b2023-11-07WarningsExact identifier
ndc (package): 49873-620-01
ndc (product): 49873-620
ndc11 (package): 49873062001
spl id: 09956557-edf5-48db-e063-6294a90a7dc8
spl set id: fe07a00a-2699-44d3-887d-bd068948ad7b

Reported adverse events (FAERS/openFDA)#

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