90000442 One Step Wart Removers

SPL v5

SPL

SPL Set ID fc9e2a45-f044-b008-e053-6394a90a056a

Route

TOPICAL

Published

Effective Date 2026-01-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (0.4 g)

Inactive Ingredients

Brown Iron Oxide Silicon Dioxide Mineral Oil Antioxidant Gs Talc White Petrolatum

Identifiers & Packaging

Pill Appearance

Color: brown

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-05-23

Description

Active Ingredient Salicylic acid 40%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

for the removal of common wart. The common wart is easily recognized by the rough 'cauliflower-like' appearance on the surface

Dosage and Administration

wash affected area and dry thoroughly
apply medicated bandage
after 48 hours, remove medicated bandage
repeat procedure every 48 hours as needed for up to 14 days (until wart is removed)
may soak wart in warm water for 5 minutes to assist in removal

Description

Active Ingredient Salicylic acid 40%

Section 44425-7

store between 20° to 25°C (68° to 77°F)
protect from excessive heat and temperatures above 40°C (140°F)

Section 50565-1

Keep out of reach of children.

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

Section 50569-3

Stop use and ask a doctor if discomfort lasts

Section 50570-1

if you are a diabetic
if you have poor blood circulation
on irritated skin or any aea that is infected or reddened
on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes

Section 51727-6

Inactive ingredients

Antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc

Section 53413-1

Questions?

1-866-360-3226

Section 55105-1

Purpose

Wart Remover

Section 55106-9

Active Ingredient

Salicylic acid 40%

Carton and Pouch

Structured Label Content

Indications and Usage (34067-9)

for the removal of common wart. The common wart is easily recognized by the rough 'cauliflower-like' appearance on the surface

Dosage and Administration (34068-7)

wash affected area and dry thoroughly
apply medicated bandage
after 48 hours, remove medicated bandage
repeat procedure every 48 hours as needed for up to 14 days (until wart is removed)
may soak wart in warm water for 5 minutes to assist in removal

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

store between 20° to 25°C (68° to 77°F)
protect from excessive heat and temperatures above 40°C (140°F)

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 50569-3 (50569-3)

Stop use and ask a doctor if discomfort lasts

Section 50570-1 (50570-1)

if you are a diabetic
if you have poor blood circulation
on irritated skin or any aea that is infected or reddened
on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes

Section 51727-6 (51727-6)

Inactive ingredients

Antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc

Section 53413-1 (53413-1)

Questions?

1-866-360-3226

Section 55105-1 (55105-1)

Purpose

Wart Remover

Section 55106-9 (55106-9)

Active Ingredient

Salicylic acid 40%

Carton and Pouch

Advanced Ingredient Data

[{"name": "BROWN IRON OXIDE", "unii": "1N032N7MFO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANTIOXIDANT GS", "unii": "2BBL73FIEU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "0.4", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "for the removal of common wart. The common wart is easily recognized by the rough 'cauliflower-like' appearance on the surface", "34068-7": "wash affected area and dry thoroughly apply medicated bandage after 48 hours, remove medicated bandage repeat procedure every 48 hours as needed for up to 14 days (until wart is removed) may soak wart in warm water for 5 minutes to assist in removal", "34071-1": "For external use only", "44425-7": "store between 20° to 25°C (68° to 77°F) protect from excessive heat and temperatures above 40°C (140°F)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away", "50569-3": "Stop use and ask a doctor if discomfort lasts", "50570-1": "if you are a diabetic if you have poor blood circulation on irritated skin or any aea that is infected or reddened on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes", "51727-6": "Inactive ingredients Antioxidant (CAS 991-84-4), iron oxides, mineral oil, petroleum hydrocarbon resin, silicon dioxide, synthetic polyisoprene rubber, talc", "53413-1": "Questions? 1-866-360-3226", "55105-1": "Purpose Wart Remover", "55106-9": "Active Ingredient Salicylic acid 40%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:15.676018 · Updated: 2026-03-14T23:12:26.991151