SPL v1
SPL
SPL Set ID 34c64003-309e-dab8-e063-6294a90a07b7
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
Cnidium Monnieri Fruit Hawthorn Leaf With Flower Lonicera Japonica Flower Stellera Chamaejasme Whole Hibiscus Syriacus Bark Sophora Flavescens Root Podophyllum

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

Uses · 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

Section 51945-4

Warnings

For external use only.

keep away from fire and flame.

only use on affected area.

Active Ingredient

Salicylic acid

Inactive Ingredients

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

Directions of Safe Use:

● wash the affected area ● may soak the tag in warm

water for 5 minutes ● dry area thoroughly ● using the

applicator(brush swab), apply one drop at a time to

sufficiently cover each tag ● allow it to fully absorb a

nd let dry ● repeat this procedure once or twice daily

as needed (until the tag falling off) for up to 12 weeks

When Using This Product :

· 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

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

Uses · 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

Section 51945-4 (51945-4)

Purpose

wart remover

Warnings

For external use only.

keep away from fire and flame.

only use on affected area.

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 the affected area ● may soak the tag in warm

water for 5 minutes ● dry area thoroughly ● using the

applicator(brush swab), apply one drop at a time to

sufficiently cover each tag ● allow it to fully absorb a

nd let dry ● repeat this procedure once or twice daily

as needed (until the tag falling off) for up to 12 weeks

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

· 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

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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