76986-015

76986-015
SPL v1
SPL
SPL Set ID 425bffc4-526f-1f25-e063-6394a90af1cf
Route
TOPICAL
Published
Effective Date 2025-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (17 g)
Inactive Ingredients
Edetate Disodium Urea Centella Asiatica Triterpenoids Triethanolamine Benzoic Acid Water Propylene Glycol Oat Rosa Rugosa Flower Polyquaternium-10 (125 Mpa.s At 2%) Butylene Glycol Lactobacillus Reuteri F275 Strain Podofilox Borneol Menthol Sodium Hydroxide Dimethyl Isosorbide Alcohol Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-30

Description

Salicylic Acid 17%

Purpose

Wart remover


Medication Information

Purpose

Wart remover

Description

Salicylic Acid 17%

Use

· for the removal of common and plantar warts

· the common wart is easily recognized by the rough "cauliflower-like"appearance on the surface.

· the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and interruption of the footprint pattern.

Stop Use

Stop Using and ask a doctor if irritation or redness develops and lasts.

Warnings

· For external use only.

· Flammable: Keep away from fire or flame.

· Ask a doctor before use if pregnant or nursing.

· Do not use if allergic to any ingredients in this product.

Ask Doctor

Stop Using and ask a doctor if irritation or redness develops and lasts.

Directions

Wash the affected area.May soak wart in warm water for 5 minutes.Dry area thoroughly.Use the brush to apply a sufficient amount to cover each wart. Let it dry.

Repeat this procedure once or twice daily as needed (until wart is removed) for up to12 weeks.

Do Not Use

·if there is any burning sensation, redness or swelling at the site of application.

·on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.

·if you have diabetes or poor blood circulation.

When Using

avoid contact with eyes, nose and mouth. If contact occurs, rinse thoroughly with water.

Active Ingredient

Salicylic Acid 17%

Other Information

·Shielded from light, sealed, stored at room temperature.

·Skin discoloration may occur during or after use .

Inactive Ingredients

Alcohol, Water, Urea, Propylene Glycol, Triethanolamine, Dimethyl Isosorbide, Menthol, Sodium Hydroxide, Podophyllotoxin, Butylene Glycol, Benzoic Acid, Polyquaternium-10, Borneol, Disodium EDTA, Avena Sativa (Oat) Kernel Extract, Rosa Rugosa Flower Extract, Centella Asiatica Extract, Lactobacillus Ferment, Potassium Hydroxide

Principal Display Panel

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a poison control center immediately.


Structured Label Content

Use

· for the removal of common and plantar warts

· the common wart is easily recognized by the rough "cauliflower-like"appearance on the surface.

· the plantar wart is recognized by its location only on the bottom of the foot, its tenderness and interruption of the footprint pattern.

Purpose

Wart remover

Stop Use

Stop Using and ask a doctor if irritation or redness develops and lasts.

Warnings

· For external use only.

· Flammable: Keep away from fire or flame.

· Ask a doctor before use if pregnant or nursing.

· Do not use if allergic to any ingredients in this product.

Ask Doctor

Stop Using and ask a doctor if irritation or redness develops and lasts.

Directions

Wash the affected area.May soak wart in warm water for 5 minutes.Dry area thoroughly.Use the brush to apply a sufficient amount to cover each wart. Let it dry.

Repeat this procedure once or twice daily as needed (until wart is removed) for up to12 weeks.

Do Not Use (Do not use)

·if there is any burning sensation, redness or swelling at the site of application.

·on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.

·if you have diabetes or poor blood circulation.

When Using

avoid contact with eyes, nose and mouth. If contact occurs, rinse thoroughly with water.

Active Ingredient

Salicylic Acid 17%

Other Information (Other information)

·Shielded from light, sealed, stored at room temperature.

·Skin discoloration may occur during or after use .

Inactive Ingredients (Inactive ingredients)

Alcohol, Water, Urea, Propylene Glycol, Triethanolamine, Dimethyl Isosorbide, Menthol, Sodium Hydroxide, Podophyllotoxin, Butylene Glycol, Benzoic Acid, Polyquaternium-10, Borneol, Disodium EDTA, Avena Sativa (Oat) Kernel Extract, Rosa Rugosa Flower Extract, Centella Asiatica Extract, Lactobacillus Ferment, Potassium Hydroxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

In case of accidental ingestion, get medical help or contact a poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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