FDA.reportPublic FDA data

Dr. Scholls Duragel Callus Removers

Manufacturer
Bayer Health Care LLC.
Effective date
2019-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:56:00

Label at a glance#

ProductDr. Scholls Duragel Callus Removers
Active ingredientSALICYLIC ACID
Label structure13 sections

Indications and uses

Uses ▪ for the removal of calluses ▪ relieves pain by removing calluses

Dosage and administration

Directions ▪ wash affected area and dry thoroughly ▪ if necessary, cut medicated disc to fit callus ▪ apply medicated disc with sticky side adhering to skin ▪ cover medicated disc with enclosed cushion ▪ after 48 hours, remove medicated disc ▪ 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#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicylic acid 40%

OTC - PURPOSE SECTION

Callus remover

Uses

INDICATIONS & USAGE SECTION

Uses

▪ for the removal of calluses

▪ relieves pain by removing calluses

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

▪ if you are a diabetic

▪ if you have 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

When using

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

Directions

▪ wash affected area and dry thoroughly

▪ if necessary, cut medicated disc to fit callus

▪ apply medicated disc with sticky side adhering to skin

▪ cover medicated disc with enclosed cushion

▪ after 48 hours, remove medicated disc

▪ 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

Other information

▪ Store between 20° to 25°C (68° to 77°F).

▪ Protect from excessive heat (temperatures above 40°C (104°F)).

INACTIVE INGREDIENT SECTION

Inactive ingredients

antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc

OTC - QUESTIONS SECTION

Questions? 1- 866-360-3226

1 pack disc carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Scholls Duragel Callus RemoversDr. Scholls Duragel Callus Removers

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-064411523-0644-1

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
MINERAL OILT5L8T28FGPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT

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
98d2c930-fd45-2393-e053-2995a90afe652e5502e5-5f7d-2666-e054-00144ff8d46c2019-12-03WarningsExact identifier
spl id: 98d2c930-fd45-2393-e053-2995a90afe65
spl set id: 2e5502e5-5f7d-2666-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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