SPL v1
SPL
SPL Set ID 37bcc410-baa4-1735-e063-6394a90acf8d
Route
TOPICAL
Published
Effective Date 2025-04-22
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 Lonicera Japonica Flower Stellera Chamaejasme Whole Hibiscus Syriacus Bark Sophora Flavescens Root Cnidium Monnieri Fruit Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-22

Description

Salicylic acid

Purpose

wart remover


Medication Information

Purpose

wart remover

Description

Salicylic acid

Uses

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

Section 51945-4

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

Active Ingredient

Salicylic acid

Inactive Ingredients

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

Directions of Safe Use:

● 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

When Using This Product :

●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

Stop Use and Ask A Doctor:

· 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.

Keep Out of Reach of Children

Keep Out Of Reach Of Children


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

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

Active Ingredient (ACTIVE INGREDIENT)

Salicylic acid

Inactive Ingredients (Inactive ingredients)

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

Directions of Safe Use: (Directions Of Safe Use:)

● 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

When Using This Product : (When using this product :)

●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

Stop Use and Ask A Doctor: (Stop use and ask a doctor:)

· 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.

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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