SPL v5
SPL
SPL Set ID 501d3ba9-ba42-4c1c-983b-492adaee039d
Route
TOPICAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (17 g)
Inactive Ingredients
Glycerin Diethylene Glycol Monoethyl Ether Iodine Glycolic Acid Ethyl Pyruvate Alcohol Pyroxylin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-01

Description

Salicylic Acid 17%

Purpose

Wart Remover


Medication Information

Purpose

Wart Remover

Description

Salicylic Acid 17%

Uses

for the removal of common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. The plantar wart exists only on the bottom of the foot and interrupts footprint pattern.

Warnings

FOR EXTERNAL USE ONLY.

Flammable

• keep away from fire or flame.

cap bottle tightlyand store at room temperature away from heat.

Do not use

• if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist.

• irritated, infected or reddened skin.

• genital warts and warts on the face.

• moles, birthmarks and warts with hair growing from them.

• mucous membranes.

When using this product

• avoid contact with eyes. If product gets into the eyes, flush with water for 15 minutes.

• avoid inhaling vapors.

Stop use and ask doctor if

• discomfort persists.

Directions

• wash affected area, may soak wart in warm water for 5 minutes

• dry area thoroughly

• apply small amount of wart remover with applicator to sufficiently cover each wart

• let dry and repeat this procedure once or twice daily until wart is removed for up to 12 weeks

Product Label

Active Ingredient

Salicylic Acid 17%

Inactive Ingredients

Collodion USP, SDA-40-B 200pf, Glycerin USP, Ethoxydiglycol (Transcutol/Carbitol), Glycolic Acid 70%, Ethyl Pyruvate, Povidone/Iodine USP

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 common and plantar warts. The common wart is easily recognized by the rough 'cauliflower-like' appearance of the surface. The plantar wart exists only on the bottom of the foot and interrupts footprint pattern.

Purpose

Wart Remover

Warnings

FOR EXTERNAL USE ONLY.

Flammable

• keep away from fire or flame.

cap bottle tightlyand store at room temperature away from heat.

Do not use

• if you are a diabetic or have poor blood circulation, except under the advice and supervision of a doctor or podiatrist.

• irritated, infected or reddened skin.

• genital warts and warts on the face.

• moles, birthmarks and warts with hair growing from them.

• mucous membranes.

When using this product

• avoid contact with eyes. If product gets into the eyes, flush with water for 15 minutes.

• avoid inhaling vapors.

Stop use and ask doctor if

• discomfort persists.

Directions

• wash affected area, may soak wart in warm water for 5 minutes

• dry area thoroughly

• apply small amount of wart remover with applicator to sufficiently cover each wart

• let dry and repeat this procedure once or twice daily until wart is removed for up to 12 weeks

Product Label (Product label)

Active Ingredient

Salicylic Acid 17%

Inactive Ingredients (Inactive ingredients)

Collodion USP, SDA-40-B 200pf, Glycerin USP, Ethoxydiglycol (Transcutol/Carbitol), Glycolic Acid 70%, Ethyl Pyruvate, Povidone/Iodine USP

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


Raw Label Data

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