MedPath

Uvzszg WART REMOVER

84010-183

Approved
Approval ID

3f227fed-f23d-e106-e063-6394a90a3fd5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 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 17% WART REMOVER

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84010-183
Application NumberM028
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic acid 17% WART REMOVER
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (7)

BORNEOLInactive
Code: M89NIB437X
Classification: IACT
SALICYLIC ACIDActive
Quantity: 17 g in 100 g
Code: O414PZ4LPZ
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CHLORHEXIDINEInactive
Code: R4KO0DY52L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

PRINCIPAL DISPLAY PANEL

17

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2025

Use

For the removal of common warts, which have a rough,cauliflower-like Appearance.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/19/2025

Active Ingredient

Salicylic acid 17%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/19/2025

Purpose

Wart remover

WARNINGS SECTION

LOINC: 34071-1Updated: 9/19/2025

Warnings

For external use only- avoid contact with eyes.
If he product gets into the eyes, rinse With water for 15 minutes.
Avoid inhaling vapors.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/19/2025

Do not use

On irritated skin, or reddened areas, or if you are diabetic or have poor blood circulation. On birthmarks, warts with hair growth.or moles.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/19/2025

When Using

If pregnant or breastfeeding, consult A health professional before use.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/19/2025

Stop Use

Stop use and ask a doctor if Discomfort persists.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/19/2025

Ask Doctor

Stop use and ask a doctor if Discomfort persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/19/2025

Keep Oot Of Reach Of Children

If swallowed, seek immediate Medical help or contact a Poison Control Center.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/19/2025

Directions

1.Wash the affected area. (soaking in warm water for 5 minutes may help.)
2. Dry thoroughly. 3. Apply a small amount to cover each wart. Let it dry 4. Repeat twice daily as needed, for up to 12 weeks.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/19/2025

Inactive ingredients

Water, polyethylene glycol, glycerin, borneol,methylparaben,chlorhexidine

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Uvzszg WART REMOVER - FDA Drug Approval Details