MedPath

QSOOWIS WART CORN REMOVER

84010-141

Approved
Approval ID

39529f87-ed50-52b8-e063-6394a90af879

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

Jiangxi Hemei Pharmaceutical Co., Ltd

DUNS: 724892056

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Salicylic acid 40% WART CORN REMOVER

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84010-141
Application NumberM028
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic acid 40% WART CORN REMOVER
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (5)

PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
SALICYLIC ACIDActive
Quantity: 40 g in 100 1
Code: O414PZ4LPZ
Classification: ACTIB
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/7/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/7/2025

Use

For the removal of warts and corns.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/7/2025

Active Ingredient

Salicylic acid 40%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/7/2025

Purpose

Wart and Corn Remover

WARNINGS SECTION

LOINC: 34071-1Updated: 7/7/2025

Warnings

For external use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 7/7/2025

Do not use

On irritated,infected, or reddened skin; on genital warts or warts on the face; on moles, birthmarks, or warts with hair growing from them;on mucous mempranes.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 7/7/2025

When Using

Avoid contact with eyes or face. If the product gets into the eyes, rinse thoroughly with water.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/7/2025

Stop Use

Stop use and ask a doctor if discomfort persists or worsens

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 7/7/2025

Ask Doctor

Ask a doctor if you have diabetes or poor blood circulation.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/7/2025

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/7/2025

Directions

Wash the affected area thoroughly with warm water. (Optional: soak the wart in warm water for 5 minutes.)Dry the area thoroughly. lf needed, cut the plaster to fit the wart. Apply the medicated plaster. Repeat every 48 hours as needed, for up to 12 weeks.Other information: Store between 59°F and 86°F(15°C and 30°C).

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/7/2025

Inactive ingredients

hard paraffin,lanolin,phenol, petrolatum

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