FDA.reportPublic FDA data

Satos Corn and Callus Remover

Manufacturer
Sato Pharmaceutical Co., Ltd.
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:18

Label at a glance#

ProductSatos Corn and Callus Remover
Active ingredientSALICYLIC ACID
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicylic acid 12%

OTC - PURPOSE SECTION

Purpose

Salicylic acid...Corn and callus remover

INDICATIONS & USAGE SECTION

Uses
■ for the removal of corns and callus
■ relieves pain by removing corns

WARNINGS SECTION

OTHER SAFETY INFORMATION

For external use only

ENVIRONMENTAL WARNING SECTION

Flammable

■ keep away from fire or flame

■ cap bottle tightly and store at room temperature away from heat.

OTC - DO NOT USE SECTION

Do not use

■ on irritated skin

■ on any area that is infected or reddened

■ if you are a diabetic

■ if you have poor blood circulation

OTC - WHEN USING SECTION

When using this product

■ avoid inhaling vapors

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if discomfort persists.


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
■ wash affected area and dry thoroughly
■ apply one drop at a time with applicator to sufficiently cover each corn/callus
■ let dry
■ repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed)
■ may soak corn/callus in warm water for 5 minutes to assist in removal

INACTIVE INGREDIENT SECTION

Inactive ingredients  collodion, lactic acid   

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

satoliqcorncart.jpg cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199213salicylic acid 12 % Topical SolutionPSN4
199213salicylic acid 120 MG/ML Topical SolutionSCD4
199213salicylic acid 12 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-078-01Satos Corn and Callus Remover9.85 mL in 1 BOTTLELIQUID9.854
49873-078-01Satos Corn and Callus Remover1 in 1 CARTONLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-078SATOS CORN AND CALLUS REMOVER (SALICYLIC ACID) LIQUID [SATO PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231205_eff7234c-4ae0-4ac2-8ab4-9312fd4dd2a3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5AT1
PYROXYLININACTIVE INGREDIENTKYR8BR2X6O1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49873-07849873-078-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PYROXYLINKYR8BR2X6OIACT
LACTIC ACID33X04XA5ATIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTIC ACIDLACTIC ACID33X04XA5ATSOLUTION / TOPICAL7.22 %w/wExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATGEL / TOPICAL30 mgExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATOINTMENT / TOPICALADJ PHExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATCREAM / TOPICAL1 %w/wExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATLOTION / TOPICAL5.7 %w/wExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATLOTION / TOPICAL5.7 %w/wExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATCREAM / TOPICAL1 %w/wExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATAEROSOL, FOAM / TOPICAL11 mgExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATSUSPENSION / TOPICAL0.7 %w/wExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATGEL / TOPICAL30 mgExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATSUSPENSION / TOPICAL0.7 %w/wExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATAEROSOL, FOAM / TOPICAL11 mgExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATOINTMENT / TOPICALADJ PHExact identifier — unii+route
14 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATSOLUTION / TOPICAL7.22 %w/wExact identifier — unii+route
14 equally ranked IID candidates

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
Satos Corn and Callus RemoverSALICYLIC ACIDSato Pharmaceutical Co., Ltd.eff7234c-4ae0-4ac2-8ab4-9312fd4dd2a32023-12-04WarningsExact identifier
ndc (package): 49873-078-01
ndc (product): 49873-078
ndc11 (package): 49873007801
spl id: 0bb872a7-eb87-b3c0-e063-6394a90a6af0
spl set id: eff7234c-4ae0-4ac2-8ab4-9312fd4dd2a3

Reported adverse events (FAERS/openFDA)#

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