Scholls Wellness Company LLC

Manufacturer
Scapa Tapes North America LLC
Effective date
2022-01-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:11:51

Label at a glance#

ProductScholls Wellness Company LLC Duragel Callus Remover
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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Salicylic Acid 40%........ Callus remover

Purpose

OTC - PURPOSE SECTION

Callus remover

Uses

INDICATIONS & USAGE SECTION

Uses

for the removal of calluses
relieves pain by removing calluses

Warnings

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

Stop use and ask a doctor

OTC - ASK DOCTOR 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 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 20ºC to 25ºC (68º to 77ºF).

Protect from excessive heat (temperatures above 40ºC (104º​F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients​ antioxidant
(CAS 991-84-4), iron oxides, mineral oil,

petroleum hydrocarbon resin, silicon dioxide,

synthetic polyisoprene rubber, talc

Questions

OTC - QUESTIONS SECTION

Questions? 1-866-360-3226

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Duragel Callus RemoverDuragel Callus Remover

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66843-06466843-064-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
d6730d97-4a1d-ae16-e053-2a95a90a31f2d6730d97-4a2b-ae16-e053-2a95a90a31f22022-01-25WarningsExact identifier
spl id: d6730d97-4a1d-ae16-e053-2a95a90a31f2
spl set id: d6730d97-4a2b-ae16-e053-2a95a90a31f2

Reported adverse events (FAERS/openFDA)#

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