MedPath

Zozdal Wart Remover

Approved
Approval ID

3b387c89-25d5-f12b-e063-6294a90a5942

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

Jiashen International Trade Limited

DUNS: 989067943

Products 1

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

WART REMOVER SALICYLIC ACID

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84867-018
Application NumberM028
Product Classification
M
Marketing Category
C200263
G
Generic Name
WART REMOVER SALICYLIC ACID
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (11)

SALICYLIC ACIDActive
Quantity: 17 g in 100 mL
Code: O414PZ4LPZ
Classification: ACTIB
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
SOPHORA FLAVESCENS ROOTInactive
Code: IYR6K8KQ5K
Classification: IACT
CHLORHEXIDINE ACETATEInactive
Code: 5908ZUF22Y
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
HYDROXYETHYLCELLULOSEInactive
Code: T4V6TWG28D
Classification: IACT
APIS MELLIFERA VENOMActive
Quantity: 2 g in 100 mL
Code: 76013O881M
Classification: ACTIB
UREAInactive
Code: 8W8T17847W
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/31/2025

labeling

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/31/2025

Direction
Wash he area aeced by ors or watswith wamwaler2.Removethe lmnerplug fiom the boe. hsathebnushino the boe cap.pes he knush ighy, and secureltghen hiecap onhe bole.3.Apythesoluion direclyto
the wart, corm, or callus,Use for an extended period if the wart or corn is large.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/31/2025

SALICYLIC ACID 17%
Bee Venom EXTRACT 2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/31/2025

wart, corn and callus remover

WARNINGS SECTION

LOINC: 34071-1Updated: 7/31/2025

WarningsFor extemal use only, Flammable-keep away from fireand flames.Do not apply to irritated skin or any areasthat are infected or reddened.Avoid usehair.genital warts.,or warts on theface ormucous membranes.Not recommended forindividuals with diabetes or poor blood circulation.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/31/2025

Please keep the product out of reach of children. lf accidentally ingested, please call the emergency center immediately

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 7/31/2025

stop use and aska docdor eskthnredhescaused by the patch does not o aay ater lour day,or yourshin snl,or yougeta rasheregular heatbeat or palpaons cuyougetsmiploms of noine overnose such as
nausea.vomiting,dizziness, weakness and rapid heartbeateyou have symptoms of an allergic reaction (such asdificully breathing or rash)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/31/2025

Apply the solution directly to the wart, corm, or callus.Use for an extended period if the wart or corn is large.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/31/2025

AQUA
GLYCERIN
LACTIC ACID
UREA
Chlorhexidine Acetate
SOPHORA FLAVESCENS EXTRACT
HYDROXYETHYLCELLULOSE
ALLANTOIN
PHENOXYETHANOL

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