FDA.reportPublic FDA data

TopCare Medicated Callus Removers

Manufacturer
Topco Associates LLC
Effective date
2026-09-24
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-09-29 01:03:01

Label at a glance#

ProductSalicylic Acid
Active ingredientSALICYLIC ACID
Label structure9 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 patch to fit callus apply adhesive side down of medicated patch onto callus cover medicated patch with pad after 48 hours, remove medicated patch 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

Label contents#

Full prescribing information#

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

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

​Stop use and ask a doctor if

OTC - STOP USE SECTION

discomfort persists

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

  • wash affected area and dry thoroughly
  • if necessary, cut medicated patch to fit callus
  • apply adhesive side down of medicated patch onto callus
  • cover medicated patch with pad
  • after 48 hours, remove medicated patch
  • 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 information

OTHER SAFETY INFORMATION

store between 15°C to 30°C (59°F to 86°F)

​Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

​Questions?

OTC - QUESTIONS SECTION

call 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare

Medicated

Callus

Removers

SALICYLIC ACID 40%

  • Effective Callus Removal Treatment
  • Protects Against Pressure & Friction

6 Pads | 4 Medicated Patches

calluscallus

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/48zrlpTop Care_Callus Remover_52-005TC-01.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9901
VINYL ACETATEINACTIVE INGREDIENTL9MK238N771

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
36800-01936800-019-04

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
SALICYLIC ACIDO414PZ4LPZACTIB
POLYVINYL ALCOHOL532B59J990IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-12-30full-release2026-06-01 01:29:27
102025-11-06monthly-update2026-06-03 17:38:32
92024-12-11full-release2026-06-01 00:42:32

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
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii+route
10 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SYSTEM / TOPICAL420 mgExact identifier — unii+route
4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TAPE / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SOLUTION / TOPICAL1.4 %w/vExact identifier — unii+route
4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TAPE / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii+route
10 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SOLUTION / TOPICAL1.4 %w/vExact identifier — unii+route
4 equally ranked IID candidates
POLYVINYL ALCOHOLPOLYVINYL ALCOHOL532B59J990SYSTEM / TOPICAL420 mgExact identifier — unii+route
4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii+route
10 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
4732c7db-b76a-b993-e063-6294a90aab3bc03e46a9-d4f0-4d1f-87f2-ac0efc4140702025-12-30WarningsExact identifier
spl set id: c03e46a9-d4f0-4d1f-87f2-ac0efc414070

Reported adverse events (FAERS/openFDA)#

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