SPL v1
SPL
SPL Set ID 41bbda9b-5570-764f-e063-6394a90a6315
Route
TOPICAL
Published
Effective Date 2025-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (8 g)
Inactive Ingredients
Angelica Sinensis Root Lithospermum Erythrorhizon Root Brucea Javanica Whole Sophora Flavescens Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-22

Description

Active ingredientSalicylic acid 896 Purpose Wart and corn remover


Medication Information

Warnings and Precautions

Warnings @For external use only @ Keep away fromheat or flame

Indications and Usage

Wash the affected area Soak the wartin warm water for 5 minutes and dry it thoroughly

Dosage and Administration

Directions @Wash the affected area @Soak the wartin warm water for 5 minutes and dry it thoroughlyApply one drop at a time with the applicator to cov.er the skin tag completely @ Allow to dry, use self-ad.hesive cushioning pads to cover the wart if desired@Repeat this process once or twice daily as needed,for up to 12 weeks, until the wart is removed (Note:For externat use, and can not be applied to healthy skin)

Description

Active ingredientSalicylic acid 896 Purpose Wart and corn remover

Section 50565-1

Keep out of reach of children, lfswallowed, get me.dical help or contact a Poison Control Center right a-Way.

Section 51727-6

Inactive ingredients Brucea javanica, Radix Angelica,Lithospermum, Sophora, Antiseptic substance

Section 51945-4

Section 55105-1

Uses For The removal of skin tags, corns, calluses, plantar warts, flat warts, common warts (less than 5 mmin size).

Section 55106-9

Active ingredientSalicylic acid 896

Purpose

Wart and corn remover


Structured Label Content

Indications and Usage (34067-9)

Wash the affected area Soak the wartin warm water for 5 minutes and dry it thoroughly

Dosage and Administration (34068-7)

Directions @Wash the affected area @Soak the wartin warm water for 5 minutes and dry it thoroughlyApply one drop at a time with the applicator to cov.er the skin tag completely @ Allow to dry, use self-ad.hesive cushioning pads to cover the wart if desired@Repeat this process once or twice daily as needed,for up to 12 weeks, until the wart is removed (Note:For externat use, and can not be applied to healthy skin)

Warnings and Precautions (34071-1)

Warnings @For external use only @ Keep away fromheat or flame

Section 50565-1 (50565-1)

Keep out of reach of children, lfswallowed, get me.dical help or contact a Poison Control Center right a-Way.

Section 51727-6 (51727-6)

Inactive ingredients Brucea javanica, Radix Angelica,Lithospermum, Sophora, Antiseptic substance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses For The removal of skin tags, corns, calluses, plantar warts, flat warts, common warts (less than 5 mmin size).

Section 55106-9 (55106-9)

Active ingredientSalicylic acid 896

Purpose

Wart and corn remover


Advanced Ingredient Data


Raw Label Data

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