83809-003 Update

83809-003 Update
SPL v2
SPL
SPL Set ID 0aa6206e-ea19-3a7e-e063-6294a90aaa38
Route
TOPICAL
Published
Effective Date 2023-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-20

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 roughcauliflower-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

Warnings

For external use only.

Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Stop using this product and see your doctor if discomfort persists for more than 72 hours

Directions

● wash affected area and dry thoroughly apply tag patch after 24 hours. remove tag patch

● repeat procedure every 24 hours for up to 14 days for tags /warts removal and up to 12 weeks for warts, until the problem hascleared.

● may hot compress wart in warm water for 5 minutes to assist in removal

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

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 roughcauliflower-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

Warnings

For external use only.

Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Stop using this product and see your doctor if discomfort persists for more than 72 hours

Directions

● wash affected area and dry thoroughly apply tag patch after 24 hours. remove tag patch

● repeat procedure every 24 hours for up to 14 days for tags /warts removal and up to 12 weeks for warts, until the problem hascleared.

● may hot compress wart in warm water for 5 minutes to assist in removal

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

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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