83781-001 Update V2

SPL v2

SPL

SPL Set ID 09769ae3-d19d-e2dd-e063-6294a90a1f64

Route

TOPICAL

Published

Effective Date 2025-03-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (40 g)

Inactive Ingredients

Paraffin Lanolin Phenol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-05

Description

Salicylic Acid 40%

Purpose

Corn and callus remover

Medication Information

Purpose

Corn and callus remover

Description

Salicylic Acid 40%

Use

■for the removal of corns,calluses and common warts

relieves pain by removing corns and calluses

Stop Use

discomfort persists

Warnings

■ For external use only

■Keep away from fire and flame

Questions

[email protected]

Ask Doctor

Ask a doctor before use if you have

■diabetes

■ poor blood circulation

Directions

■ Wash affected area:may soak wart in warm water for 5 minutes and and dry the area Remove bandage strips by peeling backing off

■lf necessary,cut medicated patch to fit wart

■Carefully apply medicated plaster

■Repeat procedure

■Every 48 hours as needed (until wart is removed)for up to 12 weeks

Do Not Use

on irritated skin or any area that is infected or reddened

When Using

if product gets in eyes,flush with water for 15 minutes.

Active Ingredient

Salicylic Acid 40%

Other Information

■ store between 20°to 25°C (68° to 77°F)

Inactive Ingredients

hard paraffin,lanolin,phenol

Principal Display Panel

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.

Structured Label Content

Use

■for the removal of corns,calluses and common warts

relieves pain by removing corns and calluses

Purpose

Corn and callus remover

Stop Use

discomfort persists

Warnings

■ For external use only

■Keep away from fire and flame

Questions

[email protected]

Ask Doctor

Ask a doctor before use if you have

■diabetes

■ poor blood circulation

Directions

■ Wash affected area:may soak wart in warm water for 5 minutes and and dry the area Remove bandage strips by peeling backing off

■lf necessary,cut medicated patch to fit wart

■Carefully apply medicated plaster

■Repeat procedure

■Every 48 hours as needed (until wart is removed)for up to 12 weeks

Do Not Use (Do not use)

on irritated skin or any area that is infected or reddened

When Using

if product gets in eyes,flush with water for 15 minutes.

Active Ingredient

Salicylic Acid 40%

Other Information (Other information)

■ store between 20°to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

hard paraffin,lanolin,phenol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (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": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOL", "unii": "339NCG44TV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "■for the removal of corns,calluses and common warts relieves pain by removing corns and calluses", "Purpose": "Corn and callus remover", "Stop Use": "discomfort persists", "Warnings": "■ For external use only ■Keep away from fire and flame", "Questions": "mqupin86@gmail.com", "Ask Doctor": "Ask a doctor before use if you have ■diabetes ■ poor blood circulation", "Directions": "■ Wash affected area:may soak wart in warm water for 5 minutes and and dry the area Remove bandage strips by peeling backing off ■lf necessary,cut medicated patch to fit wart ■Carefully apply medicated plaster ■Repeat procedure ■Every 48 hours as needed (until wart is removed)for up to 12 weeks", "Do not use": "on irritated skin or any area that is infected or reddened", "When Using": "if product gets in eyes,flush with water for 15 minutes.", "Active Ingredient": "Salicylic Acid 40%", "Other information": "■ store between 20°to 25°C (68° to 77°F)", "Inactive ingredients": "hard paraffin,lanolin,phenol", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:46.874847 · Updated: 2026-03-14T23:08:04.646392