85587-003

85587-003
SPL v1
SPL
SPL Set ID 34aff30e-6b67-357d-e063-6294a90a5ea5
Route
TOPICAL
Published
Effective Date 2025-05-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 g)
Inactive Ingredients
Borneol Speranskia Tuberculata Whole Mentha Arvensis Leaf Carthamus Tinctorius (safflower) Flower Lycopodium Clavatum Spore Glycerin Chlorhexidine Diacetate Bassia Scoparia Fruit Eucalyptus Globulus Leaf Oil Cinnamomum Cassia Bark Water Sophora Flavescens Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-09

Description

Salicylic acid 5% w/w

Purpose

Wart Remover


Medication Information

Purpose

Wart Remover

Description

Salicylic acid 5% w/w

Use

Removes: Common warts: Rough, raised growths with a "cauliflower-like" texture, typically on hands, fingers, or knees. Plantar warts: Hard, flat lesions on the soles of the feet, often tender and surrounded by thickened skin.

Stop Use

Discontinue once the wart and surrounding dead tissue detach or after the maximum treatment duration of 12 weeks.

Warnings

Safety Precautions: Flammable. Keep away from flames, sparks, or heat sources. External use only. Do not apply to eyes, mouth, or mucous membranes.

Questions

Website: https://drmiraculous.com Email: [email protected]

Ask Doctor

Consult a doctor if persistent, as possible side effects include temporary skin irritation, redness, or peeling at the application site. Darkening or lightening of the skin may also occur.

Directions

Using the applicator tip, place 1–2 drops directly onto the wart until fully covered. Let dry. Use 1–2 times daily.

Do Not Use

Avoid use on: Irritated, infected, broken, or sunburned skin. Moles, birthmarks, facial/genital warts, or warts with hair. Do not use if you have diabetes, peripheral artery disease, or poor circulation.

When Using

Wash the affected area with soap and water. Pat dry. Soak wart in warm water for 5 minutes to soften.

Active Ingredient

Salicylic acid 5% w/w

Inactive Ingredients

Water (Aqua), Carthamus Tinctorius Flower Extract, Lycopodium Clavatum Extract, Speranskia Tuberculata Extract, Glycerin, Chlorhexidine Diacetate, Sophora Flavescens Root Extract, Kochia Scoparia Fruit Extract, Mentha Arvensis Leaf Extract, Cinnamomum Camphora Bark Extract, Borneol, Eucalyptus Globulus Leaf Oil

Principal Display Panel

Keep Out of Reach of Children

Keep Out Of Reach Of Children


Structured Label Content

Use

Removes: Common warts: Rough, raised growths with a "cauliflower-like" texture, typically on hands, fingers, or knees. Plantar warts: Hard, flat lesions on the soles of the feet, often tender and surrounded by thickened skin.

Purpose

Wart Remover

Stop Use

Discontinue once the wart and surrounding dead tissue detach or after the maximum treatment duration of 12 weeks.

Warnings

Safety Precautions: Flammable. Keep away from flames, sparks, or heat sources. External use only. Do not apply to eyes, mouth, or mucous membranes.

Questions

Website: https://drmiraculous.com Email: [email protected]

Ask Doctor

Consult a doctor if persistent, as possible side effects include temporary skin irritation, redness, or peeling at the application site. Darkening or lightening of the skin may also occur.

Directions

Using the applicator tip, place 1–2 drops directly onto the wart until fully covered. Let dry. Use 1–2 times daily.

Do Not Use (Do not use)

Avoid use on: Irritated, infected, broken, or sunburned skin. Moles, birthmarks, facial/genital warts, or warts with hair. Do not use if you have diabetes, peripheral artery disease, or poor circulation.

When Using

Wash the affected area with soap and water. Pat dry. Soak wart in warm water for 5 minutes to soften.

Active Ingredient

Salicylic acid 5% w/w

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Carthamus Tinctorius Flower Extract, Lycopodium Clavatum Extract, Speranskia Tuberculata Extract, Glycerin, Chlorhexidine Diacetate, Sophora Flavescens Root Extract, Kochia Scoparia Fruit Extract, Mentha Arvensis Leaf Extract, Cinnamomum Camphora Bark Extract, Borneol, Eucalyptus Globulus Leaf Oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Keep Out Of Reach Of Children


Advanced Ingredient Data


Raw Label Data

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