Comfortzone Medicated Callus Removers

SPL v4

SPL

SPL Set ID fee137cf-48c0-4b62-b3e4-59acd504f5c3

Route

TOPICAL

Published

Effective Date 2018-08-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (40 mg)

Inactive Ingredients

Polyvinyl Alcohol, Unspecified Vinyl Acetate High Density Polyethylene

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2018-08-31

Description

Salicylic acid 40%

Purpose

Callus remover

Medication Information

Purpose

Callus remover

Description

Salicylic acid 40%

Uses

for the removal of calluses
relieves pain by removing calluses

Section 50569-3

Stop use and ask a doctor if discomfort persists

Warnings

For external use only.

Directions

wash affected area and dry thoroughlyif 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

Do Not Use

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

Questions?

call 1-877-237-0194

Active Ingredient

Salicylic acid 40%

Other Information

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

Inactive Ingredients

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Principal Display Panel

comfortzone

medicated

callus remvoers

salicylic acid

effective callus removal treatment
protects against pressure & friction

12 pads/ 8 medicated patches

Keep Out of Reach of Children.

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

Structured Label Content

Uses

for the removal of calluses
relieves pain by removing calluses

Section 50569-3 (50569-3)

Stop use and ask a doctor if discomfort persists

Purpose

Callus remover

Warnings

For external use only.

Directions

wash affected area and dry thoroughlyif 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

Do Not Use (Do not use)

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

Questions?

call 1-877-237-0194

Active Ingredient (Active ingredient)

Salicylic acid 40%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol

Principal Display Panel

comfortzone

medicated

callus remvoers

salicylic acid

effective callus removal treatment
protects against pressure & friction

12 pads/ 8 medicated patches

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

[{"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYL ACETATE", "unii": "L9MK238N77", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH DENSITY POLYETHYLENE", "unii": "UG00KM4WR7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "8", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the removal of calluses relieves pain by removing calluses", "50569-3": "Stop use and ask a doctor if discomfort persists", "Purpose": "Callus remover", "Warnings": "For external use only.", "Directions": "wash affected area and dry thoroughlyif 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", "Do not use": "if you are a diabetic have poor blood circulation on irritated skin, on any area that is infected or reddened", "Questions?": "call 1-877-237-0194", "Active ingredient": "Salicylic acid 40%", "Other information": "store between 15°C to 30°C (59°F to 86°F)", "Inactive ingredients": "acrylic adhesive, acrylic polymer, polyethylene, polyvinyl alcohol", "Principal Display Panel": "comfortzone medicated callus remvoers salicylic acid effective callus removal treatment protects against pressure & friction 12 pads/ 8 medicated patches", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:38.060452 · Updated: 2026-03-14T22:59:43.649746