SPL v1
SPL
SPL Set ID 34218a3d-8fc7-fb55-e063-6394a90a4995
Route
TOPICAL
Published
Effective Date 2025-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2.4 mg)
Inactive Ingredients
Heracleum Pubescens Whole Dimethyl Sulfoxide Eleutherococcus Sessiliflorus Whole Akebia Quinata Whole Dipsacus Asper Root Saposhnikovia Divaricata Whole Menthol, (+)- Hansenia Forbesii Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-02

Description

SALICYLIC ACID 20.0%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

1. Clean the affected area of the wart and dry it.2. Open the bottle cap and apply it to the affected area. Allow it tofuly absorb until it is completely dry.3. lf the wart or callus is large, you can extend the use time.

Dosage and Administration

Apply 3 times a day for 7-14 days.For the removal of warts, incuding plantar warts, fat warts, commonwarts, corns, and caluses,

Description

SALICYLIC ACID 20.0%

Section 50565-1

Keep out of reach of children.

Section 50566-9

You become pregnant or are planning to become pregnant whileusing this product.

lrritation or redness occurs.Condition worsens or does not improve after regular use.Keep out of reach of chlldren.If swallowed, get medical help or contact a Poison Control Centerright away.

Section 50567-7

Avoid contact with eyes, if contact occurs, flush thoroughly with water,Do not swallow.Children shouild use this product only under adult supervision.Avoid prolonged exposure to air while using, as the liquid can easilyvolatilize and crystalize.Tighten the cap after each use. lf seal is broken or missing.

Section 50570-1

On damaged skin, including cuts, abrasions, eczema, or sunbum.

If allergic to any of the ingredients in this product.

if you are pregnant or breastfeeding, unless directed by a doctor.

Section 51945-4

Section 55105-1

Plantar wart

Flat wart

Calluses

Section 55106-9

SALICYLIC ACID 20.0%


Structured Label Content

Indications and Usage (34067-9)

1. Clean the affected area of the wart and dry it.2. Open the bottle cap and apply it to the affected area. Allow it tofuly absorb until it is completely dry.3. lf the wart or callus is large, you can extend the use time.

Dosage and Administration (34068-7)

Apply 3 times a day for 7-14 days.For the removal of warts, incuding plantar warts, fat warts, commonwarts, corns, and caluses,

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

You become pregnant or are planning to become pregnant whileusing this product.

lrritation or redness occurs.Condition worsens or does not improve after regular use.Keep out of reach of chlldren.If swallowed, get medical help or contact a Poison Control Centerright away.

Section 50567-7 (50567-7)

Avoid contact with eyes, if contact occurs, flush thoroughly with water,Do not swallow.Children shouild use this product only under adult supervision.Avoid prolonged exposure to air while using, as the liquid can easilyvolatilize and crystalize.Tighten the cap after each use. lf seal is broken or missing.

Section 50570-1 (50570-1)

On damaged skin, including cuts, abrasions, eczema, or sunbum.

If allergic to any of the ingredients in this product.

if you are pregnant or breastfeeding, unless directed by a doctor.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Plantar wart

Flat wart

Calluses

Section 55106-9 (55106-9)

SALICYLIC ACID 20.0%


Advanced Ingredient Data


Raw Label Data

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