(9000075) Duragel Callus Remover

SPL v4

SPL

SPL Set ID b7256b0a-3c7e-139f-e053-2a95a90ad344

Route

TOPICAL

Published

Effective Date 2021-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (0.4 g)

Inactive Ingredients

Antioxidant Gs Brown Iron Oxide Mineral Oil Silicon Dioxide Talc

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-01-01

Description

Drug Facts

Purpose

Callus remover

Medication Information

Purpose

Callus remover

Description

Drug Facts

Uses

Uses

for the removal of calluses

relieves pain by removing calluses

Section 50565-1

Keep out of reach of children. If swallowed,

get medical help or contact a Poison Control Center right away.

Section 50570-1

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

Section 51945-4

Warnings

Warnings

For external use only

Questions

Questions? 1-866-360-3226

Directions

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

Drug Facts

Drug Facts

Active Ingredient

Active Ingredient Purpose

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

Other Information

Other information

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

Protect from excessive heat (temperatures above 40ºC (104ºF

Inactive Ingredients

Inactive ingredients antioxidant

(CAS 991-84-4), iron oxides, mineral oil,

petroleum hydrocarbon resin, silicon dioxide,

synthetic polyisoprene rubber, talc

Stop Use and Ask A Doctor

Stop use and ask a doctor if discomfort lasts

Structured Label Content

Uses

Uses

for the removal of calluses

relieves pain by removing calluses

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed,

get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Purpose

Callus remover

Warnings

Warnings

For external use only

Questions

Questions? 1-866-360-3226

Directions

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

Drug Facts

Drug Facts

Active Ingredient

Active Ingredient Purpose

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

Other Information

Other information

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

Protect from excessive heat (temperatures above 40ºC (104ºF

Inactive Ingredients

Inactive ingredients antioxidant

(CAS 991-84-4), iron oxides, mineral oil,

petroleum hydrocarbon resin, silicon dioxide,

synthetic polyisoprene rubber, talc

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if discomfort lasts

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Uses for the removal of calluses relieves pain by removing calluses", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50570-1": "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", "Purpose": "Callus remover", "Warnings": "Warnings For external use only", "Questions": "Questions? 1-866-360-3226", "Directions": "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", "Drug Facts": "Drug Facts", "Active Ingredient": "Active Ingredient Purpose Salicylic Acid 40%........ Callus remover", "Other Information": "Other information store between 20ºC to 25ºC (68º to 77ºF). Protect from excessive heat (temperatures above 40ºC (104ºF", "Inactive Ingredients": "Inactive ingredients antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc", "Stop use and ask a doctor": "Stop use and ask a doctor if discomfort lasts"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:52.301006 · Updated: 2026-03-14T23:11:49.333849