83809-005 Update

83809-005 Update
SPL v2
SPL
SPL Set ID 0af300f2-3a1e-a82d-e063-6394a90ac118
Route
TOPICAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (12 g)
Inactive Ingredients
Stellera Chamaejasme Whole Sophora Flavescens Root Lonicera Hypoglauca Flower Podophyllum Cnidium Monnieri Fruit Oil Hibiscus Syriacus Bark Hawthorn Leaf With Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-24

Description

Salicylic acid 12%

Purpose

wart remover


Medication Information

Purpose

wart remover

Description

Salicylic acid 12%

Use

●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 is recognized by its location only on the bottom of the foot,its tenderness and the interruption of the footprint pattern

Stop Use

● if discomfort persists.

●if you have diabetes or poor blood circulation.Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

keep away from fire and flame.

only use on affected area.

Directions

● wash the affected area

●may soak the wart in warm water for 5 minutes · dry area thoroughly

● using the applicator(brush or cotton swab), apply one drop at a time to sufficiently cover each wart

● allow it to fully absorb and let dry

● repeat this procedure once or twice daily as needed (until the wart is removed) for up to 12 weeks

Do Not Use

●on irritated skin or on any area that is infected or reddened

●on moles, birthmarks, warts with hair growing from them, warts on the face or mucous membranes

When Using

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

● avoid inhaling vapors

● cap the bottle tightly

●out of direct sunlight and store at room temperature away from heat

Active Ingredient

Salicylic acid 12%

Inactive Ingredients

Cnidium monnieri, Podophyllum,Hawthorn, Stellera chamaejasm, Sophora flavescens, Earthy hibiscus bark, Honeysuckle

Principal Display Panel

Keep Oot of Reach of Children

Please store this product out of the reach of childre


Structured Label Content

Use

●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 is recognized by its location only on the bottom of the foot,its tenderness and the interruption of the footprint pattern

Purpose

wart remover

Stop Use

● if discomfort persists.

●if you have diabetes or poor blood circulation.Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

keep away from fire and flame.

only use on affected area.

Directions

● wash the affected area

●may soak the wart in warm water for 5 minutes · dry area thoroughly

● using the applicator(brush or cotton swab), apply one drop at a time to sufficiently cover each wart

● allow it to fully absorb and let dry

● repeat this procedure once or twice daily as needed (until the wart is removed) for up to 12 weeks

Do Not Use (Do not use)

●on irritated skin or on any area that is infected or reddened

●on moles, birthmarks, warts with hair growing from them, warts on the face or mucous membranes

When Using

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

● avoid inhaling vapors

● cap the bottle tightly

●out of direct sunlight and store at room temperature away from heat

Active Ingredient

Salicylic acid 12%

Inactive Ingredients (Inactive ingredients)

Cnidium monnieri, Podophyllum,Hawthorn, Stellera chamaejasm, Sophora flavescens, Earthy hibiscus bark, Honeysuckle

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Please store this product out of the reach of childre


Advanced Ingredient Data


Raw Label Data

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