SPL v2
SPL
SPL Set ID 38a52656-bb8d-748e-e063-6294a90af2dd
Route
TOPICAL
Published
Effective Date 2025-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (5 g)
Inactive Ingredients
Arginine Biosaccharide Gum-1 Glyceryl Caprylate Carbomer Caprylhydroxamic Acid Parfumidine Butylene Glycol Propylene Glycol Water Sodium Hyaluronate Malic Acid Apis Mellifera Venom Mandelic Acid Xanthan Gum 1,3-beta-glucan Synthase Component Fks1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-29

Description

Salicylic Acid 5% Wart remover


Medication Information

Warnings and Precautions

For external use only. Flammable. Keep away from fire and flame

Indications and Usage

Directions:Wash the affected area.May soak wart in warm water for 5 minutes.Dry area thoroughly.Use a 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 upto 12 weeks.

Dosage and Administration

For the removal of common warts and plantar warts. Common warts have a rough

"cauliflower-like" surface and are easily recognizable. Plantar warts are located only

on the soles of the feet, tender to touch, with an interrupted footprint pattern

Description

Salicylic Acid 5% Wart remover

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact the

Poison Control Center (1-800-222-1222) right away.

Section 50566-9

On irritated skin or on any area that is infected or reddened. 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.

Section 51727-6

Water, Sodium Hyaluronate, Beta-Glucan, Arginine, Malic Acid, Mandelic Acid,

Bee Venom, Biosaccharide Gum-1, Butylene Glycol, Xanthan Gum, Parfum,

Propylene Glycol, Glyceryl Caprylate, Carbomer, Caprylhydroxamic Acid

Section 51945-4

Section 55105-1

Eliminate all warts, cornsyQuick shedding and no recurrenceySuitable for all skin type

Section 55106-9

Salicylic Acid 5% Wart remover

Section 60561-8

Store at room temperature. Avoid excessive heat (37°C/99°F).

Skin discoloration may occur during or after use


Structured Label Content

Indications and Usage (34067-9)

Directions:Wash the affected area.May soak wart in warm water for 5 minutes.Dry area thoroughly.Use a 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 upto 12 weeks.

Dosage and Administration (34068-7)

For the removal of common warts and plantar warts. Common warts have a rough

"cauliflower-like" surface and are easily recognizable. Plantar warts are located only

on the soles of the feet, tender to touch, with an interrupted footprint pattern

Warnings and Precautions (34071-1)

For external use only. Flammable. Keep away from fire and flame

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact the

Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

On irritated skin or on any area that is infected or reddened. 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.

Section 51727-6 (51727-6)

Water, Sodium Hyaluronate, Beta-Glucan, Arginine, Malic Acid, Mandelic Acid,

Bee Venom, Biosaccharide Gum-1, Butylene Glycol, Xanthan Gum, Parfum,

Propylene Glycol, Glyceryl Caprylate, Carbomer, Caprylhydroxamic Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Eliminate all warts, cornsyQuick shedding and no recurrenceySuitable for all skin type

Section 55106-9 (55106-9)

Salicylic Acid 5% Wart remover

Section 60561-8 (60561-8)

Store at room temperature. Avoid excessive heat (37°C/99°F).

Skin discoloration may occur during or after use


Advanced Ingredient Data


Raw Label Data

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