FDA.reportPublic FDA data

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 CORN REMOVER
Active ingredientSALICYLIC ACID
Label structure13 sections

Indications and uses

for the removal of corns relieves pain by removing corns

Dosage and administration

Directions wash affected area and dry thoroughly if necessary, cut medicated disc to fit corn 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 (untl corn is removed) may soak corn in warn water for 5 minutes to assist in removal

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 40%..........Corn Remover

Purpose

OTC - PURPOSE SECTION

Corn Remover

Uses

INDICATIONS & USAGE SECTION

for the removal of corns

relieves pain by removing corns

Warnings

WARNINGS SECTION

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 Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

wash affected area and dry thoroughly

if necessary, cut medicated disc to fit corn

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 (untl corn is removed)

may soak corn in warn water for 5 minutes to assist in removal

Other Information

OTHER SAFETY INFORMATION

Other information

store between 20º to 25ºC (68º to 77ºF)

protect from excessive heat and temperatures above 40ºC (104ºF)

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Duragel Corn RemoverDuragel Corn Remover

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66843-06266843-062-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANTIOXIDANT GS2BBL73FIEUIACT
BROWN IRON OXIDE1N032N7MFOIACT
MINERAL OILT5L8T28FGPIACT
TALC7SEV7J4R1UIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
d672fecf-4aa5-1eb5-e053-2995a90a505fd672fecf-4ab3-1eb5-e053-2995a90a505f2022-01-25WarningsExact identifier
spl id: d672fecf-4aa5-1eb5-e053-2995a90a505f
spl set id: d672fecf-4ab3-1eb5-e053-2995a90a505f

Reported adverse events (FAERS/openFDA)#

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