FDA.reportPublic FDA data

KPP Ultra Thick Medicated Callus Remover

Manufacturer
Cardinal Health
Effective date
2013-06-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:40:21

Label at a glance#

ProductKPP Ultra Thick Medicated Callus Remover
Active ingredientSALICYLIC ACID
Label structure7 sections

Indications and uses

For removal of calluses relieves pain by removing calluses

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 40%

Purpose

OTC - PURPOSE SECTION

Callus Removal

Uses

INDICATIONS & USAGE SECTION

  • For removal of calluses
  • relieves pain by removing calluses

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • If you are a diabetic
  • If you hae poor blood circulation
  • On irritated skin or any area that is infected or reddened
OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Discomfort lasts
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 immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Wash affected area and dry thoroughly
  • If necessary cut medicated disk to fit callus
  • Apply medicated disk with sitcky side adhering to skin
  • Cover medicated disk with enclosed cushion
  • After 48 hours, remove medicated disk
  • Repeat 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

OTHER SAFETY INFORMATION

Store between 16° and 30° C (59° and 88° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Vinyl Acetate

Preferred Plus Extra Thick Medicated Callus Remover

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box LabelBox Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61715-071-042020-10-12C16284748780-19d75b9d1-19ec-f424-e053-dadaa90a57ceKPP Ultra Thick Medicated Callus Removers
61715-071-042020-01-31C16284748780-19d75b9d1-19ec-f424-e053-dadaa90a57ceKPP Ultra Thick Medicated Callus Removers

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 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61715-07161715-071-04
43345-003

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
VINYL ACETATEL9MK238N77IACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML · Source PDF

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
b17f2eb1-b864-8258-e053-2a95a90a8aa8699db0c0-ce0b-4e7c-88b0-9a9af444a3622020-10-12WarningsExact identifier
spl set id: 699db0c0-ce0b-4e7c-88b0-9a9af444a362

Reported adverse events (FAERS/openFDA)#

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