FDA.reportPublic FDA data

Ped X Callus Removers, Medicated

Manufacturer
Pacific World Corporation
Effective date
2014-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:40:35

Label at a glance#

ProductPed X Callus Removers, Extra Thick Medicated
Active ingredientSalicylic acid
Label structure11 sections

Indications and uses

for the removal of calluses relieves pain by removing calluses

Dosage and administration

wash affected area and dry thoroughly. if necessary, cut medicated disk to fit callus before applying. after 48 hours remove the medicated disk. repeat this procedure every 48 hours as needed for up to 14 days (until callus is removed). may soak callus in warm water for 5 minutes to assist in removal.

Storage and handling

store between 59°F-86°F (15°C-30°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 40%

Purpose

OTC - PURPOSE SECTION

Callus remover

Uses

INDICATIONS & USAGE SECTION

  • for the removal of calluses
  • relieves pain by removing calluses

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on irritated skin or any area that is infected or reddened
  • if you are a diabetic
  • if you have poor blood circulation.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly.
  • if necessary, cut medicated disk to fit callus before applying.
  • after 48 hours remove the medicated disk.
  • repeat this procedure every 48 hours as needed for up to 14 days (until callus is removed).
  • may soak callus in warm water for 5 minutes to assist in removal.

Other information

STORAGE AND HANDLING SECTION

  • store between 59°F-86°F (15°C-30°C)

Inactive ingredient

INACTIVE INGREDIENT SECTION

Vinyl acetate.

Questions?

OTC - QUESTIONS SECTION

1(541)-476-3178, 8 am to 5 pm (M–F), PST

PRINCIPAL DISPLAY PANEL - 4 mg Patch Cello Pack - Extra Thick

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pedx™

new!

Extra Thick Medicated

Callus Removers

dissolving relief from tough

CALLUSES

6 cushions
4 medicated disks

Principal Display Panel - 4 mg Patch Cello Pack - Extra Thick
Principal Display Panel - 4 mg Patch Cello Pack - Extra Thick

PRINCIPAL DISPLAY PANEL - 4 mg Patch Cello Pack - Medicated

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pedx™

new!

Medicated

Callus Removers

dissolving relief from tough

CALLUSES

6 cushions
4 medicated disks

Principal Display Panel - 4 mg Patch Cello Pack - Medicated
Principal Display Panel - 4 mg Patch Cello Pack - Medicated

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240559salicylic acid 40 % Medicated PatchPSN2
240559salicylic acid 0.4 MG/MG Medicated PatchSCD2
240559salicylic acid 40 % Medicated PatchSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60193-400-022020-01-31C16284748780-19d75b9d0-0d4b-f424-e053-dadaa90a57cePed X™ Callus Removers
60193-401-022020-01-31C16284748780-19d75b9d0-0d4b-f424-e053-dadaa90a57cePed X™ Callus Removers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60193-400-01Ped X Callus Removers, Medicated1 in 1 PATCHPATCH12
60193-400-02Ped X Callus Removers, Medicated4 in 1 CELLO PACKPATCH42
60193-401-01Ped X Callus Removers, Extra Thick Medicated1 in 1 PATCHPATCH12
60193-401-02Ped X Callus Removers, Extra Thick Medicated4 in 1 CELLO PACKPATCH42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60193-400PED X CALLUS REMOVERS, EXTRA THICK MEDICATED (SALICYLIC ACID) PATCH PED X CALLUS REMOVERS, MEDICATED (SALICYLIC ACID) PATCH [PACIFIC WORLD CORPORATION]2Legacy NDC, 2 package rows20141021_613cfe0b-8917-4226-a7eb-c6e150f23b9e.zip
60193-401PED X CALLUS REMOVERS, EXTRA THICK MEDICATED (SALICYLIC ACID) PATCH PED X CALLUS REMOVERS, MEDICATED (SALICYLIC ACID) PATCH [PACIFIC WORLD CORPORATION]2Legacy NDC, 2 package rows20141021_613cfe0b-8917-4226-a7eb-c6e150f23b9e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic acidACTIVE INGREDIENTO414PZ4LPZ2
Salicylic acidACTIVE MOIETYO414PZ4LPZ2
Vinyl acetateINACTIVE INGREDIENTL9MK238N772

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
60193-40160193-401-01, 60193-401-02
60193-40060193-400-01, 60193-400-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic acidO414PZ4LPZACTIB
Vinyl acetateL9MK238N77IACT
Salicylic acidO414PZ4LPZACTIB
Vinyl acetateL9MK238N77IACT

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
0d3afc45-2982-40b5-ac28-4f616a6cddae613cfe0b-8917-4226-a7eb-c6e150f23b9e2014-10-17WarningsExact identifier
spl id: 0d3afc45-2982-40b5-ac28-4f616a6cddae
spl set id: 613cfe0b-8917-4226-a7eb-c6e150f23b9e

Reported adverse events (FAERS/openFDA)#

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